Search Results
within category "Digestive Systems & Liver Disease"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors
This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The
goal is to find the highest dose of MM-398 that can be given safely when it is used together
with the chemotherapy drug Cyclophosphamide.
• Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma,
neuroblastoma, or osteosarcoma
• Disease progression after prior therapy in locally advanced or metastatic setting
• Measurable or evaluable disease based on the Response Evaluation Criteria in Solid
Tumors (RECIST v1.1) criteria
• Age 12 months to <21 years
• Adequate bone marrow reserves, hepatic function, and renal function
• Recovered from effects of any prior surgery or cancer therapy
• Patients 18 years or older will provide written consent. A parent or legal guardian of
a patient <18 years of age will provide informed consent and patients 11 to 18 years
of age will provide written assent or as per participating institutional policy.
Exclusion Criteria:
• Clinically significant gastrointestinal disorders
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled
blood pressure
• Active infection or unexplained fever
• Known hypersensitivity to any of the components of MM-398 or other liposomal products
• Recent Investigational therapy
• Pregnant or breast feeding; females of child-bearing potential must test negative for
pregnancy at the time of enrollment
Drug: MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
Neuroblastoma, Sarcoma, Ewing Sarcoma, Mycosis Fungoides, Rhabdomyosarcoma, Osteosarcoma, Recurrent or Refractory Solid Tumors, Brain and Nervous System, Eye and Orbit, Anus, Bones and Joints, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Ear, Esophagus, Gall Bladder, Head and Neck, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Nose, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Throat, Thyroid, Urinary Bladder, Uterine (Endometrial), Vulva, Hodgkins Lymphoma, Kaposis sarcoma, Other Hematopoietic, Small Intestine, Soft Tissue
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy (MILES)
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12
months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's
milk allergic children and to assess the long-term safety and therapeutic benefit with
Viaskin Milk.
Call 214-648-5005 studyfinder@utsouthwestern.edu
John Bird
108478
All
2 Years to 17 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02223182
STU 092014-046
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Eligibility criteria for study enrollment:
Inclusion Criteria:
• Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed
assent form (IAF) for subjects ≥7 years, or as per local or country specific
guidelines or regulations.
• Male or female subjects 2 to 17 years old at Visit 1.
• Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with
systemic symptoms related to ingestion of milk or dairy products.
• Subjects currently following a strict cow's milk-free diet, with no consumption of
dairy or baked milk products.
• Cow's milk-specific IgE level at screening ≥10 kU/L
• Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm.
• Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins
(approximately ≤9.4 mL of cow's milk).
• Negative urine pregnancy test for female subjects of childbearing potential. Female
subjects of childbearing potential must agree and commit to use effective medical
methods of contraception for the entire duration of their participation in the study.
Sexual abstinence will be accepted as an effective method of contraception for girls
below 15 years of age.
• Ability to perform spirometry procedures in accordance with the American Thoracic
Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak
expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects <8 years of age
who have documented inability to adequately perform spirometry can perform only the
PEF evaluation. Subjects <5 years of age may be enrolled if they had no clinical
features of moderate or severe persistent asthma severity (as defined by the 2007
National Heart, Lung, and Blood Institute [NHLBI] Guidelines) within 1 year before
Visit 1.
• Subjects and/or parents/guardians willing to comply with all study requirements during
participation in the study.
Exclusion Criteria:
• History of severe anaphylaxis to cow's milk resulting in hypotension, hypoxia or
neurological compromise (collapse, loss of consciousness or incontinence) or requiring
mechanical ventilation.
• Pregnancy or lactation.
• Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value at
Visit 1 for subjects ≥6 years and able to perform the spirometry, or PEF <80% of
predicted value at Visit 1 for subjects performing only the PEF measurements.
• Any clinical features of moderate or severe persistent asthma severity (as defined by
the 2007 NHLBI guidelines) and high daily doses of inhaled corticosteroids.
• Known allergy to the Viaskin patch materials or excipients, or to any of the
components of the food challenge formulas other than the cow's milk proteins.
• Allergy or known history of reaction to Tegaderm® medical dressing with no possibility
to use an alternative adhesive dressing authorized by the sponsor in replacement.
• Subjects having objective symptoms to the placebo formula leading to stopping the
challenge during the screening DBPCFC.
• Severe reaction during the screening DBPCFC defined as need for intubation, and/or
hypotension persisting after epinephrine administration, and/or the need for >2 doses
of epinephrine.
• Symptomatic allergy to pollens with symptoms during the pollen season that might
interfere with the symptoms observed during the DBPCFC, if the DBPCFC is performed
during the pollen season. Screening of such subjects should be made out of the pollen
season.
• Inability to discontinue short-acting antihistamines for 3 days or long-acting
antihistamines for 5 to 7 days (depending on the half-life) before the DBPCFC.
• Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 and/or use
of systemic short-acting corticosteroids within 4 weeks before Visit 1 or use of
systemic long-acting or short-acting corticosteroids during screening (unless used to
treat symptoms triggered by the DBPCFC or triggered by accidental allergen
consumption; in the latter case DBPCFC must then be scheduled after a minimum of 7
wash-out days).
• Subjects with asthma conditions meeting 1 or several criteria below:
• Uncontrolled persistent asthma (as defined by the 2007 NHLBI guidelines) or
subject being treated with a combination therapy of medium or high daily dose of
inhaled corticosteroid with a long acting inhaled β2-agonist. Intermittent
asthmatic subjects who require intermittent use of inhaled corticosteroids for
rescue are permitted.
• At least 2 systemic corticosteroid courses for asthma within 1 year before Visit
1 or 1 oral corticosteroid course for asthma within 3 months before Visit 1, or
during screening (unless used to treat symptoms triggered by the DBPCFC).
• Prior intubation/mechanical ventilation due to asthma within 2 years before Visit
1, or during screening.
• Upper respiratory infection or gastroenteritis within 7 days of DBPCFC (DBPCFC must
then be rescheduled at least 7 days after resolution of these conditions).
• Any history of milk immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or
specific oral tolerance induction).
• Prior history of any other food allergen immunotherapy (eg, oral immunotherapy,
sublingual immunotherapy or specific oral tolerance induction) within 5 years before
Visit 1.
• Subjects currently under aeroallergen immunotherapy and unwilling or unable to
discontinue at the time of Visit 1. Aeroallergen Immunotherapy must be discontinued at
the time of Visit 1.
• Use of any anti-IgE drug (eg, omalizumab), any immunomodulatory therapy, or any
biological agent therapy (eg, anti-tumor necrosis factor drugs) within 1 year before
Visit 1, or during screening.
• Generalized dermatologic diseases (eg, severe atopic dermatitis, uncontrolled
generalized eczema, icthyosis vulgaris) with no intact zones to apply the Viaskin
patch, or urticarial and mast cells disorders such as chronic idiopathic urticaria.
• Subject and/or subject's parents/guardians with obvious excessive anxiety and unlikely
to cope with the conditions of a food challenge.
• Past or current disease, including but not limited to active eosinophilic
gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy,
uncontrolled disease (hypertension, diabetes, psychiatric disorder, cardiac disease),
or other disorders (eg, liver, gastrointestinal, kidney, cardiovascular, pulmonary
disease or blood disorder) which in the opinion of the Investigator or the sponsor may
affect the subject's participation in the study or place the subject at increased
risk.
• Subjects and/or parents/guardians unable to use the epinephrine auto-injector properly
in spite of being adequately trained.
• Contraindicated condition for the use of epinephrine.
• Use of any investigational drug or device, or participation in another interventional
clinical study within 3 months before Visit 1.
• Subjects receiving beta-blockers or Angiotensin converting-enzyme (ACE) inhibitors.
• Subjects unable to follow the protocol requirements.
TransMedics (OCS) Liver Trial: Preserving and Assessing Donor Livers for Transplantation (Liver PROTECT)
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness
of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Malcolm MacConmara
157434
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02522871
STU 092015-076
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Inclusion Criteria:
• Registered male or female primary Liver transplant candidate
• Age ≥18 years old
• Signed: 1) written informed consent document and 2) authorization to use and disclose
protected health information
Exclusion Criteria:
• Acute, fulminant liver failure
• Prior solid organ or bone marrow transplant
• Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic
serum creatinine of >3 mg/dl for >2 weeks and/or requiring hemodialysis
• Multi-organ transplant
• Ventilator dependent
• Dependent on > 1 IV inotrope to maintain hemodynamics
Device: OCS™ Liver System, Other: Control
Liver Transplantation, Liver Preservation for Transplant
A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma
This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab
and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is
defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects
must not have received prior systemic therapy for advanced HCC in keeping with the first-line
setting of this study.
• Patient must have a histologically confirmed diagnosis hepatocellular carcinoma; known
fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC will be
excluded
• Locally advanced or metastatic disease
• Patients with locally advanced or metastatic disease must have disease deemed not
amenable to surgical and/or locoregional therapies or patients who have progressed
following surgical and/or locoregional therapies.
• Measurable disease, as defined as lesions that can accurately be measured in at least
one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced
dynamic imaging (magnetic resonance imaging or computed tomography).
• Child-Pugh Score A
• Age ≥ 18 years
• ECOG Performance score of 0-1
• Life expectancy greater than 6 months
• Following baseline laboratory values:
1. Total bilirubin ≤ 2.0 mg/ml
2. INR ≤ 1.7
3. Hgb ≥ 8.5 g/dl
4. AST, ALT ≤5 times ULN
5. Platelet count ≥ 50,000/mm3
6. Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min
7. Albumin ≥ 2.5 g/dl
8. Absolute neutrophil ≥ 1,500 cells/mm3
• Male and female subjects of child bearing potential must agree to use an adequate
method of contraception for the course of the study through 120 days after the last
dose of study medication
• Women of childbearing potential must have a negative pregnancy test within 72 hours
prior to receiving the first dose of study medication
• Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC,
or HCV-HCC defined as follows:
HBV-HCC: Controlled (treated) hepatitis B subjects will be allowed if they meet the
following criteria:
Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be
less than 100 IU/mL prior to first dose of study drug. Subjects on active HBV therapy with
viral loads under 100 IU/ml should stay on the same therapy throughout study treatment.
Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV
viral load under 100 IU/mL do not require HBV anti-viral prophylaxis.
HCV-HCC: active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.
Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible.
Subjects with chronic infection by HCV who are treated (successfully or treatment failure)
or untreated are allowed on study. In addition, subjects with successful HCV treatment are
allowed as long as there are ≥4 weeks between completion of HCV therapy and start of study
drug.
Successful HCV treatment definition: SVR12.
•Prior therapy is allowed provided the following are met: at least 4 weeks since prior
locoregional therapy including surgical resection, chemoembolization, radiotherapy, or
ablation. Provided target lesion has increased in size by 25% or more or the target lesion
was not treated with locoregional therapy. Patients treated with palliative radiotherapy
for symptoms will be eligible 1 week after treatment as long as the target lesion is not
the treated lesion.
Exclusion Criteria:
• Prior liver transplant;
• Patient who has received previous systemic therapy for HCC;
• Clinically significant, uncontrolled heart disease and/or recent events including any
of the following:
• History of acute coronary syndromes (including myocardial infarction, unstable angina,
coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic
pericarditis within 12 months prior to screening;
• History of documented congestive heart failure (New York Heart Association functional
classification III-IV);
• Documented cardiomyopathy;
• Patient has a left ventricular ejection fraction <40% as determined by MUGA scan or
ECHO (MUGA and ECHO are not required prior to enrollment);
• Known human immunodeficiency virus (HIV) positive (testing not required);
• History of thromboembolic events (including both pulmonary embolism and deep venous
thrombus but not including tumor thrombus) within the last 6 months;
• Hypersensitivity to IV contrast; not suitable for pre-medication;
• Active or fungal infections requiring systemic treatment within 7 days prior to
screening;
• Known history of, or any evidence of, interstitial lung disease or active
non-infectious pneumonitis;
• Evidence of poorly controlled hypertension which is defined as systolic blood pressure
>150 mmHg or diastolic pressure >90 mmHg despite optimal medical management;
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication;
• Active, known, or suspected autoimmune disease with the following exceptions i)
Subjects with vitiligo, type I diabetes mellitus, resolved childhood asthma or atopy
are permitted to enroll; ii) Subjects with suspected autoimmune thyroid disorders may
be enrolled if they are currently euthyroid or with residual hypothyroidism requiring
only hormone replacement.
iii) Subjects with psoriasis requiring systemic therapy must be excluded from enrollment
• Patient has any other concurrent severe and/or uncontrolled medical condition that
would, in the investigator's judgment, cause unacceptable safety risks, contraindicate
patient participation in the study or compromise compliance with the protocol (e.g.
chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral
infections, etc.);
• Patient has any other concurrent severe and/or uncontrolled medical condition that
would, in the investigator's judgment, cause unacceptable safety risks, contraindicate
patient participation in the study or compromise compliance with the protocol (e.g.
chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral
infections, etc.);
• Known history of active bacillus tuberculosis;
• Subjects with a condition requiring systemic treatment with either corticosteroids (>
10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days
of study administration. Inhaled or topical steroids and adrenal replacement doses >10
mg/day prednisone equivalents are permitted in the absence of autoimmune disease;
• Patient who has received radiotherapy ≤ 4 weeks prior to study entry. Palliative
radiotherapy for symptomatic control is acceptable (if completed at least 2 weeks
prior to study drug administration and no additional radiotherapy for the same lesion
is planned);
• Patient has had major surgery within 14 days prior to starting study drug or has not
recovered from major side effects (tumor biopsy is not considered as major surgery);
• Clinically apparent ascites on physical examination, ascites present on imaging
studies is allowed;
• Patient has a known hypersensitivity to any of the excipients of bavituximab or
pembrolizumab or monoclonal antibody;
• Active gastrointestinal bleeding within previous 2 months;
• History of any condition requiring anti-platelet therapy (aspirin >300 mg/day,
clopidogrel >75 mg/day);
• Prisoners or subjects who are involuntarily incarcerated;
• Symptomatic or clinically active brain metastases;
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after contraception and until the termination of gestation, confirmed by a
positive hCG laboratory test;
• Prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents;
• Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection
(anti-HCV Ab(+) and detectable HCV RNA) at study entry.
A Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) and With Bempegaldesleukin Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL)
Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the
Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic
administration of bempegaldesleukin. After determination of the recommended Phase 2 dose
(RP2D) of NKTR-262, between 6 and 18 patients may be enrolled at the RP2D to further
characterize the safety and tolerability profile of the combination of NKTR 262 plus
bempegaldesleukin (doublet) or NKTR 262 plus bempegaldesleukin in combination with nivolumab
(triplet) in Cohorts A and B, respectively. In the Phase 2 dose expansion portion, patients
will be treated with doublet or triplet in the relapsed/refractory setting and earlier lines
of therapy.
• Histologically confirmed diagnosis of a locally advanced (not amenable to curative
therapy such as surgical resection) metastatic cancer of the following histologies:
melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC),
renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma
(HNSCC), or sarcoma.
• Life expectancy > 12 weeks as determined by the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Measurable disease per RECIST 1.1.
• Patients enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be
refractory to all therapies known to confer clinical benefit to their disease.
• Fresh tumor tissue available for cellular characterization and programmed cell death
protein 1 (PD-L1) status.
• Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT
injection; lesions must be accessible for baseline and on-treatment biopsies. Any
liver lesion targeted for injection must not exceed 50 mm at the time of injection.
• Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
Key
Exclusion Criteria:
• Use of an investigational agent or an investigational device within 21 days before
administration of first dose of study drug(s).
• Patients treated with prior interleukin-2 (IL-2).
• Patients who have been previously treated with a toll-like receptor (TLR) agonist
(excluding topical agents) and patients who have received experimental cancer
vaccines.
• Patients who have received systemic interferon (IFN)α within the previous 6 months
prior to enrollment to the study.
• Other active malignancy, except non-melanomic skin cancer
• Evidence of clinically significant interstitial lung disease or active, noninfectious
pneumonitis.
• Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients
must have recovered from all radiation-related toxicities, not required
corticosteroids and have not had radiation pneumonitis.
• Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for
women at Screening.
History of unstable or deteriorating cardiac disease within the previous 6 months prior to
screening including but not limited to the following:
• Unstable angina or myocardial infarction.
• Congestive heart failure (NYHA Class III or IV).
• Uncontrolled clinically significant arrhythmias.
• Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic
retinopathy, retinal hemorrhage, macular degeneration).
• Uveal melanoma will be excluded
• Patients with tumor that invade the superior vena cava or other major blood vessels.
Additional general and tumor specific inclusion and exclusion criteria will apply.
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared
to placebo in participants with HCC who have undergone complete resection or have achieved a
complete response after local ablation, and who are at high risk of recurrence
For more information regarding Bristol Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
• Participants with a first diagnosis of HCC who have undergone a curative resection or
ablation
• Participants are eligible to enroll if they have non-viral related-HCC, or if they
have HBV-HCC, or HCV-HCC
• Child-Pugh Score 5 or 6
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Any evidence of tumor metastasis or co-existing malignant disease
• Participants previously receiving any prior therapy for HCC, including loco-regional
therapies
• Participants who have undergone a liver transplant or those who are in the waiting
list for liver transplantation
• Participants who have received a live/attenuated vaccine within 30 days of
randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles,
mumps, rubella [MMR]).
Other protocol defined inclusion/exclusion criteria could apply
Phase 1/2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety,
tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib
(also known as LOXO-292) administered orally to patients with advanced solid tumors,
including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors
with RET activation.
For Phase 1
• Patients with a locally advanced or metastatic solid tumor who:
• have progressed on or are intolerant to standard therapy, or
• no standard therapy exists, or in the opinion of the Investigator, are not
candidates for or would be unlikely to tolerate or derive significant clinical
benefit from standard therapy, or
• decline standard therapy
• Prior MKIs with anti-RET activity are allowed.
• A RET gene alteration is not required initially. Once adequate PK exposure is
achieved, evidence of RET gene alteration in tumor and/or blood is required as
identified through molecular assays, as performed for clinical evaluation.
• Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as
appropriate to tumor type.
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance
Score (LPS) ≥ 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the
first dose of study treatment.
• Adequate hematologic, hepatic and renal function.
• Life expectancy of at least 3 months.
For Phase 2
As for phase 1 with the following modifications:
•For Cohort 1 (up to 250 patients): Subjects must have received prior standard therapy
appropriate for their tumor type and stage of disease, or in the opinion of the
Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate
standard of care therapy.
• Cohorts 1 and 2: enrollment will be restricted to patients with evidence of a RET gene
alteration in tumor.
• Cohorts 1 and 2: at least one measurable lesion as defined by RECIST 1.1 or RANO, as
appropriate to tumor type and not previously irradiated.
• Cohorts 3 and 4: Enrollment closed.
• Cohort 5: (up to 200 patients):
• Cohorts 1 and 2 without measurable disease;
• MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with
neuroendocrine features/differentiation, or poorly differentiated thyroid cancers
with other RET alteration/activation may be allowed with prior Sponsor approval;
• cfDNA positive for a RET gene alteration not known to be present in a tumor
sample.
• Cohort 6 (up to 50 patients):
• Patients who otherwise are eligible for Cohorts 1, 2 or 5 who discontinued
another RET inhibitor due to intolerance may be eligible with prior Sponsor
approval.
Key Exclusion Criteria (Phase 1 and Phase 2):
• Phase 2 Cohorts 1 and 2: an additional known oncogenic driver.
• Cohorts 3 and 4: Enrollment closed.
• Cohorts 1, 2 and 5: prior treatment with a selective RET inhibitor
Notes:
Patients otherwise eligible for Cohorts 1, 2, and 5 who discontinued another selective RET
inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval.
•Investigational agent or anticancer therapy (including chemotherapy, biologic therapy,
immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5
half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292
(selpercatinib). In addition, no concurrent investigational anti-cancer therapy is
permitted.
Note:
Potential exception for this exclusion criterion will require a valid scientific
justification and approval from the Sponsor.
• Major surgery (excluding placement of vascular access) within 4 weeks prior to planned
start of LOXO-292 (selpercatinib).
• Radiotherapy with a limited field of radiation for palliation within 1 week of planned
start of LOXO-292 (selpercatinib), with the exception of patients receiving radiation
to more than 30% of the bone marrow or with a wide field of radiation, which must be
completed at least 4 weeks prior to the first dose of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of
starting study treatment with the exception of alopecia and Grade 2, prior
platinum-therapy related neuropathy.
• Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated
spinal cord compression. Patients are eligible if neurological symptoms and CNS
imaging are stable and steroid dose is stable for 14 days prior to the first dose of
LOXO-292 (selpercatinib) and no CNS surgery or radiation has been performed for 28
days, 14 days if stereotactic radiosurgery [SRS].
• Clinically significant active cardiovascular disease or history of myocardial
infarction within 6 months prior to planned start of LOXO-292 (selpercatinib) or
prolongation of the QT interval corrected (QTcF) > 470 msec.
• Required treatment with certain strong CYP3A4 inhibitors or inducers and certain
prohibited concomitant medications.
Drug: LOXO-292 (selpercatinib)
Lymphoma, Non-Small Cell Lung Cancer, Colon Cancer, Medullary Thyroid Cancer, Any Solid Tumor, Brain and Nervous System, Eye and Orbit, Anus, Bones and Joints, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Stomach, Thyroid, Urinary Bladder, Hodgkins Lymphoma, Small Intestine, Soft Tissue
LOXO-292, KIF5B-RET, M918T, CCDC6-RET, RET-PTC1, NCOA4-RET, RET-PTC, RET-PTC3, RET-PTC4, PRKAR1A-RET, RET-PTC2, GOLGA5-RET, RET-PTC5, ERC1-RET, KTN1-RET, RET-PTC8, HOOK3-RET, PCM1-RET, TRIM24-RET, RET-PTC6, TRIM27-RET, TRIM33-RET, RET-PTC7, AKAP13-RET, FKBP15-RET, SPECC1L-RET, TBL1XR1-RET, BCR-RET, FGRF1OP-RET, RFG8-RET, RET-PTC9, ACBD5-RET, MYH13-RET, CUX1-RET, KIAA1468-RET, FRMD4A-RET, SQSTM1-RET, AFAP1L2-RET, PPFIBP2-RET, EML4-RET, PARD3-RET, G533C, C609F, C609G, C609R, C609S, C609Y, C611F, C611G, C611S, C611Y, C611W, C618F, C618R, C618S, C620F, C620R, C620S, C630R, C630Y, D631Y, C634F, C634G, C634R, C634S, C634W, C634Y, K666E, E768D, L790F, V804L, V804M, A883F, S891A, R912P, CLIP1-RET, Y806C, RET fusion, RET alteration, RET mutation, RET rearrangement, RET translocation, Neoplasms by Site, Neoplasms, Non-Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Respiratory Tract Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Medullary Thyroid Cancer, Papillary Thyroid Cancer, Thyroid Diseases, Thyroid Neoplasms, Cancer of the Thyroid, Cancer of Thyroid, Neoplasms, Thyroid, Thyroid Ademona, Thyroid Cancer, Thyroid Carcinoma, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms, Thoracic Neoplasms, CNS tumor, Primary CNS tumor, Cancer of Colon, Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic, Malignant tumor of Breast, Mammary Cancer, Mammary Carcinoma, Human, Mammary Neoplasm, Human, Neoplasms, Breast, Tumors, Breast, Human Mammary Carcinoma, Malignant Neoplasm of Breast, Breast Carcinoma, Breast Tumors, Cancer of the Breast, Breast Neoplasms, Breast Cancer, RET Inhibitor, MTC, NSCLC, selpercatinib
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study
The objective of this study is to evaluate the safety, tolerability, and antitumor activity
of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in
subjects with metastatic pancreatic cancer.
1. Age ≥ 18
2. Written and signed informed consent must be obtained
3. ECOG Performance Status 0 or 1
4. Weight ≥ 35 kg
5. Subjects must have histologically or cytologically, confirmed pancreatic
adenocarcinoma:
Cohort A: Subjects with previously untreated metastatic pancreatic adenocarcinoma (1st
line metastatic disease) not previously treated with systemic therapies.
Cohort B: Subjects with metastatic pancreatic adenocarcinoma previously treated with
gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin)
2nd line metastatic disease
6. Subjects must have at least 1 measurable lesion according to RECIST v1.1
7. All subjects must consent to providing archival tumor specimens
Exclusion Criteria:
1. Receipt of any conventional or investigational anticancer therapy within 21 days or
palliative radiotherapy within 14 days prior to the scheduled first dose of study
treatment.
2. Prior receipt of any immune-related therapy
3. Concurrent enrollment in another therapeutic clinical study. Enrollment in
observational studies will be allowed
4. Subjects with a history of venous thrombosis within the past 3 months
5. Subjects with prior history of myocardial infarction, transient ischemic attack, or
stroke in the last 3 months prior to start of treatment
6. Active or prior documented autoimmune or inflammatory disorders within the past 3
years prior to the start of treatment
7. Other invasive malignancy within 2 years.
8. Any history of leptomeningeal disease or cord compression.
9. Current or prior use of immunosuppressive medication within 14 days prior to the first
dose
Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (ADMIRE-CD-II)
The purpose of this study is to evaluate the combined remission of complex perianal fistulas,
defined as the clinical assessment at Week 24 of closure of all treated external openings
that were draining at baseline despite gentle finger compression, and absence of collections
greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central
magnetic resonance imaging (MRI) assessment at Week 24.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Tasneem Ahmed
116579
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03279081
STU 052018-069
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Signed informed consent.
2. Participants of either gender greater than or equal to (>=) 18 years and less than or
equal to (<=) 75 years of age.
3. Participants with CD diagnosed at least 6 months prior to Screening visit in
accordance with accepted clinical, endoscopic, histological and/or radiological
criteria.
4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a
maximum of 3 external openings based on clinical assessment; a central reading of a
locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to
confirm location of the fistula and potential associated perianal abscess(es).
Fistula(s) must have been draining for at least 6 weeks prior to Screening visit.
Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are
not allowed in this study. A complex perianal fistula is defined as a fistula that
meets one or more of the following criteria :
• High inter-sphincteric, high trans-sphincteric, extra-sphincteric or
suprasphincteric.
• Presence of >=2 external openings.
• Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at
least 2 dimensions on MRI must be confirmed to have been drained adequately by
the surgeon during the preparation curettage in order to be eligible.
5. Clinically controlled, nonactive or mildly active CD, during the last six months prior
to Screening visit with:
• A patient reported outcomes (PRO-2) score <14 at Screening, AND
• A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic
mucosa:
•If colonoscopy data are not available within 6 months prior to Screening:
• A simple endoscopic score for Crohn's Disease (SES-CD) <=6 with absence of rectal
ulcers larger than 0.5 cm must be documented in a colonoscopy performed at
Screening before randomization.
•If colonoscopy data are available within 6 months prior to Screening, the
following must be documented, otherwise a new colonoscopy (as above) will be
mandatory:
• The absence of ulcers larger than 0.5 cm in the colonic mucosa AND
• the improvement or no worsening in abdominal pain and/or in the diarrhea,
sustained for one week or more, since the last colonoscopy was performed in the
clinical records until Screening visit.
AND
o No hemoglobin decrease >=2.0 gram per deciliter (g/dL) or an unexplained rising
C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above
the referenced upper limit of normal (ULN) (unless the rise is due to a known process
other than luminal Crohn's Disease), since the last colonoscopy was performed as
compared to results during the Screening visit.
AND
o no initiation or intensification of treatment with corticosteroids,
immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last
endoscopy up to Screening visit.
6. Participants whose perianal fistulas were previously treated and have shown an
inadequate response or a loss of response while they were receiving either an
immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or
vedolizumab or ustekinumab, or having documented intolerance to any of these
treatments administered at least at approved or recommended doses during the minimum
period mentioned:
• Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3
milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day),
or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for
the study.
• TNFalpha antagonists:
• Infliximab: at least 14 weeks treatment at the approved doses for induction
and/or maintenance in Crohn´s disease prior to screening for the study. For
induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the
same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8
weeks, or more frequently.
• Adalimumab: at least 14 weeks treatment at the approved doses for induction
and/or maintenance in Crohn's disease prior to screening for the study. For
induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks
after. For maintenance: 40 mg subcutaneously every other week, or weekly.
• Certolizumab l: at least 14 weeks treatment at the approved doses for induction
and/or maintenance in Crohn´s disease prior to screening for the study. For
induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks
after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
• Anti-integrin: at least 14 weeks treatment of the approved dose for induction
and/or maintenance in Crohn´s disease prior to screening for the study. For
induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8
weeks.
• Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in
Crohn´s disease prior to screening for the study. For induction: Ustekinumab,
approximately 6mg/kg intravenously initially then followed by 90 mg
subcutaneously every 8 weeks.
7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at
screening (sensitive to 25 international units [IU] human chorionic gonadotropin
[hCG]). Both WCBP or male participants participating in this study, with a WCBP as
partner, must agree to use an adequate method of contraception during the entire
duration of the study. An adequate method of contraception is defined as complete,
non-periodic sexual abstinence (refraining from heterosexual intercourse),
single-barrier method, vasectomy, adequate hormonal contraception (to have started at
least 7 days prior to Screening visit), or an intra-uterine device (to have been in
place for at least 2 months prior to Screening visit).
Exclusion Criteria:
1. Concomitant rectovaginal or rectovesical fistula(s).
2. Participant naïve to prior specific medical treatment for complex perianal fistula(s)
including immunosuppressant (IS) or anti-TNFs.
3. Presence of a perianal collection >2 cm in at least two dimensions on the central
reading MRI at Screening visit that was not adequately drained as confirmed by the
surgeon during the preparation procedure (week -3 to day 0).
4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of
large >0.5 cm ulcers in the rectum) that make impossible to follow the surgery
procedure manual.
5. Participant with diverting stomas.
6. Active, uncontrolled infection requiring parenteral antibiotics.
7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior
to the Preparation visit.
8. Participants with major alteration on any of the following laboratory tests or
increased risk for the surgical procedure:
• Serum creatinine levels >1.5 times the ULN
• Total bilirubin >1.5 ULN
• Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) >3 times ULN
• Hemoglobin <10.0 g/dL
• Platelets <75.0*10^9/L
• Albuminemia <3.0 g/dL
9. Suspected or documented infectious enterocolitis within two weeks prior to Screening
visit.
10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening
visit. Participants with basal-cell carcinoma of the skin completely resected outside
the perineal region can be included.
11. Current or recent (within 6 months prior to the Screening visit) history of severe,
progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other
than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease
that may result in participants increased risk from study participation and/or lack of
compliance with study procedures.
12. Participants with primary sclerosing cholangitis.
13. Participants with known chronically active hepatopathy of any origin, including
cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface
antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive
serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to
Screening.
14. Congenital or acquired immunodeficiencies, including participants known to be HIV
carriers
15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco
Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI
contrast).
16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip
replacements or severe claustrophobia).
17. Severe trauma within 6 months prior to Screening visit.
18. Pregnant or breastfeeding women.
19. Participants who do not wish to or cannot comply with study procedures.
20. Participants currently receiving, or having received any investigational drug within 3
months prior to Screening visit.
21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy
cannot be enrolled into this clinical study.
22. Any major surgery of the GI tract (including one or more segments of the colon or
terminal ileum) within 6 months prior the screening or any minor surgery of the GI
tract within 3 months prior to screening.
23. Participants who had local perianal surgery other than drainage for the fistula within
6 months prior to the Screening visit, or those who may need surgery in the perianal
region for reasons other than fistulas at the time of inclusion in the study.
24. Contraindication to the anaesthetic procedure.
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW)
The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and
oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by
Progression Free Survival (PFS).
This study will also evaluate efficacy, safety and tolerability of zolbetuximab, as well as
its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity
profile of zolbetuximab will be evaluated as well.
• A female subject is eligible to participate if she is not pregnant (negative serum
pregnancy test at screening; female subjects with elevated serum beta human chorionic
gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing
are eligible) and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance throughout the treatment
period and for 6 months after the final study treatment administration
• Female subject must agree not to breastfeed starting at screening and throughout the
study period, and for 6 months after the final study treatment administration.
• Female subject must not donate ova starting at screening and throughout the study
period, and for 6 months after the final study treatment administration.
• A male subject with female partner(s) of childbearing potential:
• must agree to use contraception during the treatment period and for 6 months
after the final study treatment administration.
• A male subject must not donate sperm during the treatment period and for 6 months
after the final study treatment administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain
abstinent or use a condom for the duration of the pregnancy or time partner is
breastfeeding throughout the study period and for 6 months after the final study
treatment administration.
• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
• Subject has radiologically confirmed locally advanced unresectable or metastatic
disease within 28 days prior to randomization.
• Subject has radiologically evaluable disease (measurable and/or non-measurable disease
according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For
subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before
randomization, the lesion must either be outside the field of prior radiotherapy or
have documented progression following radiation therapy.
• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to
strong membranous staining as determined by central IHC testing.
• Subject has a HER2-negative tumor as determined by local or central testing on a
gastric or GEJ tumor specimen.
• Subject has ECOG performance status 0 or 1.
• Subject has predicted life expectancy ≥ 12 weeks.
• Subject must meet all of the following criteria based on the centrally or locally
analyzed laboratory tests collected within 14 days prior to randomization. In case of
multiple central laboratory data within this period, the most recent data should be
used to determine eligibility.
• Hemoglobin (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they
have a post-transfusion Hgb ≥ 9 g/dL.
• Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
• Platelets ≥ 100x10^9/L
• Albumin ≥ 2.5 g/dL
• Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or
< 3.0 x ULN if liver metastases are present)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
without liver metastases (or ≤ 5 x ULN if liver metastases are present)
• Estimated creatinine clearance ≥ 30 mL/min
• Prothrombin time/international normalized ratio (PT/INR) and partial
thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving
anticoagulation therapy)
Exclusion Criteria:
• Subject has received prior systemic chemotherapy for locally advanced unresectable or
metastatic gastric or GEJ adenocarcinoma. However, subject may have received either
neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months
prior to randomization.
• Subject has received radiotherapy for locally advanced unresectable or metastatic
gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered
from any related toxicity.
• Subject has received treatment with herbal medications or other treatments that have
known antitumor activity within 28 days prior to randomization.
• Subject has received systemic immunosuppressive therapy, including systemic
corticosteroids within 14 days prior to randomization. Subjects using a physiologic
replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day
of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of
systemic corticosteroids or receiving systemic corticosteroids as premedication for
radiologic imaging contrast use are allowed.
• Subject has received other investigational agents or devices within 28 days prior to
randomization.
• Subject has prior severe allergic reaction or intolerance to known ingredients of
zolbetuximab or other monoclonal antibodies, including humanized or chimeric
antibodies.
• Subject has known immediate or delayed hypersensitivity, intolerance or
contraindication to any component of study treatment.
• Subject has prior severe allergic reaction or intolerance to any component of CAPOX.
• Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome
with persistent/recurrent vomiting.
• Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude
the subject from participation.
• Subject has a known history of a positive test for human immunodeficiency virus (HIV)
infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag))
or C infection. NOTE: Screening for these infections should be conducted per local
requirements.
• For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab)
positive, an HB deoxyribonucleic acid (DNA) test will be performed and if
positive, the subject will be excluded.
• Subjects with positive hepatitis C virus (HCV) serology, but negative HCV
ribonucleic acid (RNA) test are eligible.
• Subjects treated for HCV with undetectable viral load results are eligible.
• Subject has an active autoimmune disease that has required systemic treatment within
the past 3 months prior to randomization.
• Subject has active infection requiring systemic therapy that has not completely
resolved within 7 days prior to randomization.
• Subject has significant cardiovascular disease, including any of the following:
• Congestive heart failure (defined as New York Heart Association Class III or IV),
myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary
artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within
6 months prior to randomization.
• History of clinically significant ventricular arrhythmias (i.e., sustained
ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
• QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female
subjects
• History or family history of congenital long QT syndrome
• Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate
controlled atrial fibrillation for > 1 month prior to randomization are
eligible).
• Subject has a history of central nervous system (CNS) metastases and/or carcinomatous
meningitis from gastric/GEJ cancer..
• Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep
tendon reflexes is the sole neurological abnormality.
• Subject has had a major surgical procedure ≤ 28 days prior to randomization.
• Subject is without complete recovery from a major surgical procedure ≤ 14 days
prior to randomization.
• Subject has psychiatric illness or social situations that would preclude study
compliance.
• Subject has another malignancy for which treatment is required.
• Subject has any concurrent disease, infection, or co-morbid condition that interferes
with the ability of the subject to participate in the study, which places the subject
at undue risk or complicates the interpretation of data.
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation (IMbrave050)
This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus
bevacizumab compared with active surveillance in participants with completely resected or
ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
• Participants with a first diagnosis of HCC who have undergone either a curative
resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only)
within 4-12 weeks of randomization
• Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA
only)
• Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread
• Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen,
pelvis, and head prior to and following curative procedure
• Full recovery from surgical resection or ablation within 4 weeks prior to
randomization
• High risk for HCC recurrence after resection or ablation
• For patients who received post-operative transarterial chemoembolization: full
recovery from the procedure within 4 weeks prior to randomization
• For patients with resected HCC, availability of a representative baseline tumor tissue
sample
• ECOG Performance Status of 0 or 1
• Child-Pugh Class A status
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Evidence of residual, recurrent, or metastatic disease at randomization
• Clinically significant ascites
• History of hepatic encephalopathy
• Prior bleeding event due to untreated or incompletely treated esophageal and/or
gastric varices within 6 months prior to randomization
• Have received more than 1 cycle of adjuvant TACE following surgical resection
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan
• Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable
arrhythmia, or unstable angina
• History of malignancy other than HCC within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death
• Active tuberculosis
• Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug, may affect
the interpretation of the results, or may render the patient at high risk from
treatment complications
• Pregnant or breastfeeding, or intending to become pregnant during the study or within
5 months after the final dose of atezolizumab or within 6 months after the final dose
of bevacizumab. Women of childbearing potential must have a negative serum pregnancy
test result within 14 days prior to Day 1 of Cycle 1.
• Co-infection with HBV and HCV
• Co-infection with HBV and hepatitis D viral infection
• Clinical significant uncontrolled or symptomatic hypercalcemia
• Any treatment for HCC prior to resection or ablation, including systemic therapy and
locoregional therapy such as TACE
• Treatment with systemic immunostimulatory or immunosuppressive agents
• Inadequately controlled arterial hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• Significant vascular disease
• Evidence of bleeding diathesis or significant coagulopathy
• Current or recent use of aspirin or full-dose oral or parenteral anticoagulants
• Core biopsy within 3 days of Day 1 of Cycle 1
• History of GI fistula, GI perforation, or intra-abdominal abscess
• Serious non-healing or dehiscing wound
• Major surgical procedure within four weeks
• Chronic daily treatment with a non-steroidal anti-inflammatory drug
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
This is an open-label phase1/2, multi-center trial to evaluate the efficacy, safety,
tolerability and immunogenicity of INO-3107 in participants with HPV-6 and/or HPV-11
associated recurrent respiratory papillomatosis (RRP). The trial population is divided into
two cohorts: Cohort A: Participants with diagnoses of Juvenile-Onset RRP as defined by age at
first diagnosis of RRP < 12 years. Cohort B: Participants with Adult-onset RRP as defined by
age at first diagnosis of RRP ≥ 12 years. A safety run-in will be performed with up to six
participants across cohort A and B with a one week waiting period between each enrolled
participant.
Call 214-648-5005 studyfinder@utsouthwestern.edu
I-Fan Mau
99252
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04398433
STU-2020-0247
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
• Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma
• Requirement for frequent surgical intervention to remove or resect respiratory
papilloma, as defined by at least 2 interventions per year for three years prior to
Day 0; participants must have a history of at least two surgical procedures during the
third year prior to their screening date and during the second year prior to their
screening date and at least one surgical procedure with a requirement of a future
surgical procedure during the year prior to their screening date
• Must be an appropriate candidate for upcoming surgical intervention as per
Investigator judgment and RRP Staging Assessment score
• Adequate bone marrow, hepatic, and renal function
• Participants must :
• Be of non-child bearing potential(≥12 months of non-therapy-induced amenorrhea,
confirmed by follicle-stimulating hormone [FSH], if not on hormone replacement)
• Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in
females)
• Agree to use one highly effective or combined contraceptive methods that result
in a failure rate of <1% per year during the treatment period and at least
through week 12 after last dose
• Agree to abstinence from penile-vaginal intercourse, when this is the
participant's preferred and usual lifestyle
Key
Exclusion Criteria:
• Recipient of therapy directed towards HPV disease (other than surgery or ablation)
including but not limited to anti-virals (including cidofovir), radiation,
chemotherapy, anti-angiogenic therapy (including bevacizumab), therapeutic vaccination
(including Gardasil), or therapy with an experimental agent within 6 months prior to
Day 0
• Ongoing or recent (within 1 year) evidence of autoimmune disease that required
treatment with systemic immunosuppressive treatments, with the exception of: vitiligo,
childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that
requires only hormone replacement, or psoriasis that does not require systemic
treatment
• Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy
within 28 days prior to the first dose of trial treatment, including systemic
corticosteroids
• High risk of bleeding or require the use of anticoagulants for management of a known
bleeding diathesis
• Recipient of any live virus vaccine within 4 weeks prior to the first dose of trial
treatment
• History of clinically significant, medically unstable disease which, in the judgment
of the Investigator, would jeopardize the safety of the participant, interfere with
trial assessment or evaluation, or otherwise impact the validity of the trial results
• Fewer than two acceptable sites are available for IM injection considering the deltoid
and anterolateral quadriceps muscles. Study treatment should not be given within 2
centimeters (cm) of a tattoo, keloid or hypertrophic scar. If there is implanted
metal, implanted device, within the same limb the use of the deltoid muscle on the
same side of the body is excluded
• Prisoners or participants who are compulsory detained (involuntary incarceration) for
treatment of either a psychiatric or physical (i.e. infectious disease) illness
• Any medical or psychological or non-medical condition that might interfere with the
participation or safety of the participant, as determined by the investigator
The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
This research study is evaluating the use of specialized testing of solid tumors including
sequencing. The process of performing these specialized tests is called tumor profiling. The
tumor profiling may result in identifying changes in genes of the tumor that indicate that a
particular therapy may have activity. This is called an individualized cancer therapy (iCat)
recommendation. The results of the tumor profiling and, if applicable, the iCat
recommendation will be returned.
• Age -- Age ≤ 30 years at time of initial qualifying solid tumor diagnosis
• Diagnosis -- Histologic diagnosis of solid malignancy (excluding brain tumors and
lymphoma) that meets at least one of the following criteria:
• Refractory, defined as tumor progression after initiation of standard first line
therapy without having achieved a prior partial or complete remission OR Biopsy
proven residual disease at the completion of planned standard initial front-line
therapy.
• Recurrent, defined as tumor progression after achieving a prior partial or
complete remission
• Newly diagnosed high risk disease, defined as having an expected event free
survival of < 50% at 2 years.
• Lacks definitive diagnosis or classical genomic findings after histologic review
and standard molecular testing (rare tumor group).
• Examples include (eligibility not limited to these examples):
• Histology typically associated with a fusion in which fusion is not detected.
• Ewing-like sarcoma
• Undifferentiated sarcoma
• Inflammatory myofibroblastic tumor without ALK fusion
• Infantile fibrosarcoma without NTRK fusion
• Specimen Samples
• Sufficient tumor specimen available to meet the minimum requirements for
profiling from diagnosis or progression / recurrence
--- OR
• Surgery / biopsy planned as part of clinical care that is anticipated to yield
sufficient material to meet the minimum requirements for profiling; OR
• Patient has already had molecular profiling and patient has not yet started
matched targeted therapy based on the report .
Exclusion Criteria:
• No Therapy Planned
-- Patients who have declined further anticancer therapy will be excluded.
• Performance Status
-- Patients with Lansky (age < 16 years) or Karnofsky (age ≥16 years) score < 50 will
be excluded.
• Life Expectancy -- Patients with anticipated life expectancy < 3 months will be
excluded.
Genetic: Genetic testing and GAIN report
Sarcoma, Pediatric Solid Tumor, Brain and Nervous System, Other, Eye and Orbit, Anklylosing Spondylitis, Anus, Bones and Joints, Breast - Female, Breast - Male, Carcinoid Tumor, Cervix, Colon, Corpus Uteri, Ear, Esophagus, Gall Bladder, Head and Neck, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Nose, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Throat, Thyroid, Urinary Bladder, Uterine (Endometrial), Vulva, Heart, Kaposis sarcoma, Small Intestine, Soft Tissue, Ill - Defined Sites
Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer
The study will perform a clinical study evaluating the safety and tolerability of nintedanib
when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic
pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast
enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and
microvessel density.
1. Signed and dated written informed consent prior to admission to the study;
2. Histologically or cytologically confirmed metastatic or locally advanced
adenocarcinoma of the pancreas;
3. At least one measurable disease lesion according to Response Evaluation Criteria In
Solid Tumors (RECIST, version 1.1);
4. Age ≥ 18 years;
5. No more than one prior line of non-gemcitabine/nab-paclitaxel containing systemic
therapy for metastatic/locally advanced pancreatic cancer;
6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1;
7. Women of childbearing potential must have a negative pregnancy test (urine or serum)
within 14 days prior to registration; (Note: contraception in patients with
reproductive capacity will be considered to be of childbearing potential unless
surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or
post-menopausal for at least two years.)
8. Adequate biological parameters at baseline (obtained within 14 days prior to
registration).
9. If elevated liver function tests develop at the time of initial presentation or
develop during workup and are the result of mechanical obstruction of the biliary
drainage by tumor compression or invasion, a biliary drain may be placed. If drainage
allows the liver function tests to come within inclusion criteria, the patient may be
enrolled.
Exclusion Criteria:
1. More than one systemic therapy regimen of any type for metastatic or locally advanced
disease. Adjuvant gemcitabine that ended more than 6 months from diagnosis of
recurrent disease is not considered as a regimen;
2. Prior treatment with nintedanib or any other VEGFR inhibitor;
3. Known hypersensitivity to nintedanib, gemcitabine and nab-Paclitaxal peanut or soya or
any other trial drug, their excipients or to contrast media;
4. Chemo-, hormon-, radio-(except for brain and extremities) or immunotherapy or therapy
with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks
prior to treatment with the trial drug;
5. Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
6. Persistence of clinically relevant therapy related toxicity from previous chemo and/or
radiotherapy;
7. Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with
radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone
therapy will be allowed if administered as stable dose for at least one month before
randomization);
8. Leptomeningeal disease;
9. Radiographic evidence of cavitary or necrotic tumors;
10. Treatment with other investigational drugs or treatment in another clinical trial
within the past 4 weeks before start of therapy or concomitantly with the trial;
11. Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose
heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous
devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic
acid < 325mg per day);
12. Major injuries and/or surgery within the past 4 weeks prior to start of study
treatment with incomplete wound healing and/or planned surgery during the on-treatment
study period;
13. History of clinically significant hemorrhagic or thromboembolic event in the past 6
months;
14. Known inherited predisposition to bleeding or thrombosis;
15. Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina,
history of infarction within the past 12 months prior to start of study treatment,
congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion);
16. Proteinuria CTCAE grade 2 or greater;
17. Creatinine > 1.5 x ULN or GFR < 45 mL/min;
18. Hepatic function: total bilirubin outside of normal limits; ALT or AST > 1.5 ULN in
pts without liver metastasis. For Pts with liver metastasis: total bilirubin outside
of normal limits, ALT or AST > 2.5 ULN;
19. Coagulation parameters: International Normalized Ratio (INR) > 2, prothrombin time
(PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN;
20. Absolute neutrophil count (ANC) < 1500/mL, platelets < 100,000/mL, Hemoglobin < 9.0
g/dl;
21. Any known active cancer other than pancreatic primary;
22. Active serious infections in particular if requiring systemic antibiotic or
antimicrobial therapy;
23. Active or chronic hepatitis C and/or B infection;
24. Gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug;
25. Serious illness or concomitant non-oncological disease such as neurologic,
psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or
laboratory abnormality that may increase the risk associated with study participation
or study drug administration and in the judgment of the investigator would make the
patient inappropriate for entry into the study;
26. Pregnancy or breast feeding female;
27. Psychological, familial, sociological or geographical factors potentially hampering
compliance with the study protocol and follow-up schedule;
28. Active alcohol or drug abuse;
29. Significant weight loss (> 20% of BW) within past 6 months prior to inclusion into the
trial or actual body weight of less than 50 kg;
30. Patients who are sexually active and unwilling to use a medically acceptable method of
contraception (e.g. such as implants, injectable, combined oral contraceptives, some
intrauterine devices, sexual abstinence or vasectomized partner for participating
females, condoms for participating males) during the trial and for at least three
months after end of active therapy.
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to
cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified
colorectal cancer that has spread from where it started to other places in the body and
cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may
interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of
tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them
from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and
irinotecan hydrochloride in treating patients with colorectal cancer.
• STEP 1 INITIAL REGISTRATION: HER2 TESTING
• Patients must have histologically or cytologically documented adenocarcinoma of the
colon or rectum that is metastatic or locally advanced and unresectable
• Mutation results:
• All patients must have molecular testing performed in a Clinical Laboratory
Improvement Act (CLIA) certified lab which includes which includes KRAS and NRAS
gene and exon 15 of BRAF gene (BRAF V600E mutation); patients with any known
activating mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61] and
exon 4 [codons 117 and 146]) of KRAS/NRAS genes and in exon 15 (BRAFV600E
mutation) of BRAF gene are not eligible
• Patients must not have been treated with any of the following prior to step 1 initial
registration:
• Cetuximab, panitumumab, or any other monoclonal antibody against EGFR or
inhibitor of EGFR
• HER-2 targeting for treatment of colorectal cancer; patients who have received
prior trastuzumab or pertuzumab for other indications such as prior history of
adjuvant or neoadjuvant breast cancer treatment prior to the development of
advanced colorectal cancer are eligible
• Patients must not have had history of severe toxicity and intolerance to or
hypersensitivity to irinotecan or any other study drug; patients must not have had a
severe infusion-related reaction during any prior therapy with pertuzumab or
trastuzumab
• Patients must have tumor slides available for submission for HER-2 testing; HER-2
testing must be completed by the central lab prior to step 2 randomization
• Patients must be informed of the investigational nature of this study and must sign
and give informed consent in accordance with institutional and federal guidelines; for
step 1 initial registration, the appropriate consent form is the step 1 consent form
• As a part of the OPEN registration process the treating institution's identity is
provided in order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system
• STEP 2 RANDOMIZATION
• Patients must have HER-2 amplification as determined by central testing (3+ or 2+ by
immunohistochemistry and HER-2 gene amplification by in situ hybridization with a
ratio of HER-2 gene signals to centromere 17 signals >= 2.0)
• Patients must have measurable disease that is metastatic or locally advanced and
unresectable; imaging used to assess all disease per RECIST 1.1 must have been
completed within 28 days prior to step 2 randomization; all disease must be assessed
and documented on the Baseline Tumor Assessment Form
• Patients must have had at least one prior regimen of systemic chemotherapy for
metastatic or locally advanced, unresectable disease; patients must have progressed
following the most recent therapy; prior treatment with irinotecan is allowed; for
patients that received adjuvant chemotherapy: prior treatment for metastatic disease
is not required for patient who experienced disease recurrence during or within 6
months of completion of adjuvant chemotherapy; if the patient received one line of
adjuvant treatment and had disease recurrence after 6 months of completing
chemotherapy, patients will only be eligible after failing one additional line of
chemotherapy used to treat the metastatic or locally advanced, unresectable disease;
patients who have received >= 3 lines of systemic chemotherapy for metastatic or
locally advanced, unresectable disease are not eligible
• Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy
at least 14 days prior to step 2 randomization and all toxicity must be resolved to
Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 (with
the exception of CTCAE v4.0 grade 2 neuropathy) prior to step 2 randomization
• Brain metastases are allowed if they have been adequately treated with radiotherapy or
surgery and stable for at least 30 days prior to step 2 randomization; eligible
patients must be neurologically asymptomatic and without corticosteroid treatment for
at least 7 days prior to step 2 randomization
• Patients must have a Zubrod performance status of 0 or 1
• Patients must have a complete physical examination and medical history within 28 days
prior to step 2 randomization
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 75,000/mcL
• Hemoglobin >= 9 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 5 x
institutional upper limit of normal (IULN)
• Bilirubin =< 1.5 mg/dL
• Calculated creatinine clearance > 30 ml/min within 14 days prior to step 2
randomization
• Patients who have had an echocardiogram performed within 6 months prior to step 2
randomization must have ventricular ejection fraction (left ventricular ejection
fraction [LVEF]) >= 50% or >= within normal limits for the institution
• Patients must not have an uncontrolled intercurrent illness including, but not limited
to diabetes, hypertension, severe infection, severe malnutrition, unstable angina,
class III-IV New York Heart Association (NYHA) congestive heart failure, ventricular
arrhythmias, active ischemic heart disease, or myocardial infarction within 6 months
prior to step 2 randomization
• Patients must not have any known previous or concurrent condition suggesting
susceptibility to hypersensitivity or allergic reactions, including, but not limited
to: known hypersensitivity to any of the study treatments or to excipients of
recombinant human or humanized antibodies; patients with mild or seasonal allergies
may be included after discussion with the study chairs
• Patients must not be planning treatment with other systemic anti-cancer agents (e.g.,
chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of
protocol-specified anti-cancer therapy including concurrent investigational agents of
any type
• No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade
lesions such as incidental appendix carcinoid, or any other cancer from which the
patient has been disease and treatment free for two years; prostate cancer patients on
active surveillance are eligible
• Patients must not be pregnant or nursing; females of child-bearing potential must have
a negative serum pregnancy test within 7 days prior to registration; women/men of
reproductive potential must have agreed to use an effective contraceptive method while
on study and for at least 7 months after the last dose of study treatment; a woman is
considered to be of "reproductive potential" if she has had menses at any time in the
preceding 12 consecutive months; in addition to routine contraceptive methods,
"effective contraception" also includes heterosexual celibacy and surgery intended to
prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a
hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any
point a previously celibate patient chooses to become heterosexually active during the
time period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures
• Patients must be given the opportunity to consent to the optional submission of tissue
for future research
• Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines; the appropriate consent form for this registration is the step 2 consent
form
• STEP 2 RANDOMIZATION: As a part of the Oncology Patient Enrollment Network (OPEN)
registration process the treating institution's identity is provided in order to
ensure that the current (within 365 days) date of institutional review board approval
for this study has been entered in the system
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have documented disease
progression while on CETIRI (Arm 2) on this protocol; the Follow-up Tumor Assessment
Form documenting disease progression must be submitted to Southwest Oncology Group
(SWOG) prior to step 3 crossover registration; registration to step 3 crossover must
be within 28 days of discontinuation of CETIRI protocol treatment; patients going off
treatment for any other reason are not eligible
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a Zubrod performance
status of 0 or 1
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): ANC >= 1,500/mcL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Platelets >= 75,000/mcL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Hemoglobin >= 9 g/dL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): AST and ALT both =< 5 x institutional upper
limit of normal (IULN)
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Bilirubin =< 1.5 mg/dL
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Calculated creatinine clearance > 30 ml/min
within 14 days prior to step 3 crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have left ventricular ejection
fraction (LVEF) >= 50% or >= lower limit of normal for the institution by
echocardiogram within 14 days prior to step 3 crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must have a magnesium, potassium,
calcium, sodium, bicarbonate, and chloride performed within 14 days prior to step 3
crossover registration
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines; the appropriate consent form
for this registration is the step 2 consent form
• STEP 3 CROSSOVER REGISTRATION (OPTIONAL): As a part of the OPEN registration process
the treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
This partially randomized phase II/III trial studies how well, in combination with surgery,
cisplatin and combination chemotherapy works in treating children and young adults with
hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin,
doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan,
sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving combination chemotherapy may kill more tumor cells than one type of
chemotherapy alone.
• Patients in Group F must have a body surface area (BSA) >= 0.6 m^2
• Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age; patients who are unable to walk because of
paralysis, but who are up in a wheelchair, will be considered ambulatory for the
purpose of assessing the performance score
• Patients must be newly diagnosed with histologically-proven primary pediatric hepatic
malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted
below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified,
should be classified and treated per hepatoblastoma treatment arms; note that rapid
central pathology review is required in some cases; please note: all patients with
histology as assessed by the institutional pathologist consistent with pure small cell
undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by
immunohistochemistry (IHC) according to the practices at the institution
• Patients with histology consistent with pure SCU must have positive INI1/SMARCB1
staining
• For all Group A patients, WDF status as determined by rapid review will be used to
further stratify patients to Group A1 or A2
• For Groups B, C and D, rapid review is required if patients are either >= 8 years
of age or have an alphafetoprotein (AFP) =< 100 at diagnosis
• For all Groups E and F patients, rapid central pathology review is required
• In emergency situations when a patient meets all other eligibility criteria and has
had baseline required observations, but is too ill to undergo a biopsy safely, the
patient may be enrolled without a biopsy
• Clinical situations in which emergent treatment may be indicated include, but are
not limited to, the following circumstances:
• Anatomic or mechanical compromise of critical organ function by tumor (e.g.,
respiratory distress/failure, abdominal compartment syndrome, urinary
obstruction, etc.)
• Uncorrectable coagulopathy
• For a patient to maintain eligibility for AHEP1531 when emergent treatment is
given, the following must occur:
• The patient must have a clinical diagnosis of hepatoblastoma, including an
elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility
criteria at the time of emergent treatment
• Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a
patient will be ineligible if any chemotherapy is administered prior to
AHEP1531 enrollment
• Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to
undergoing a diagnostic biopsy, pathologic review of material obtained in the
future during either biopsy or surgical resection must either confirm the
diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be
included in the analysis of the study aims
• Patients may have had surgical resection of the hepatic malignancy prior to
enrollment; all other anti-cancer therapy for the current liver lesion is prohibited
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60
mL/min/1.73 m^2 or
• A serum creatinine based on age/gender as follows:
• Age: maximum serum creatinine (mg/dL)
• 1 month to < 6 months: 0.4 (male and female)
• 6 months to < 1 year: 0.5 (male and female)
• 1 to < 2 years: 06 (male and female)
• 2 to < 6 years: 0.8 (male and female)
• 6 to < 10 years: 1 (male and female)
• 10 to < 13 years: 1.2 (male and female)
• 13 to < 16 years: 1.5 (male), 1.4 (female)
• >= 16 years: 1.7 (male), 1.4 (female)
• Total bilirubin =< 5 x upper limit of normal (ULN) for age
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 10 x upper limit of normal (ULN) for age
• Shortening fraction of >= 28% by echocardiogram (for patients on
doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior
to study enrollment) or
• Ejection fraction of >= 47% by echocardiogram or radionuclide angiogram (for patients
on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks
prior to study enrollment)
• Group F patients only: QT/corrected QT (QTc) interval =< 450 milliseconds for males
and =< 470 milliseconds for females (assessed within 8 weeks prior to study
enrollment)
• Normal pulmonary function tests (including diffusion capacity of the lung for carbon
monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at
rest, known requirement for supplemental oxygen) (for patients receiving chemotherapy
[Groups A2, B, C, D, E2, F]); for patients who do not have respiratory symptoms or
requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required
• All patients and/or their parents or legal guardians must sign a written informed
consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Exclusion Criteria:
• Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents,
local therapy (embolization, radiofrequency ablation, and laser); therefore, patients
with a pre-disposition syndrome who have a prior malignancy are not eligible
• Patients who are currently receiving another investigational drug
• Patients who are currently receiving other anticancer agents
• Patients with uncontrolled infection
• Patients who previously received a solid organ transplant, other than those who
previously received an orthotopic liver transplantation (OLT) as primary treatment of
their hepatocellular carcinoma
• Patients with hypersensitivity to any drugs on their expected treatment arm
• Group C: Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
• Group D:
• Patients with chronic inflammatory bowel disease and/or bowel obstruction
• Patients with concomitant use of St. John's wort, which cannot be stopped prior
to the start of trial treatment
• Group F:
• Patients with peripheral sensitive neuropathy with functional impairment
• Patients with a personal or family history of congenital long QT syndrome
• This criteria apply ONLY to patients who will receive chemotherapy (all groups other
than Groups A1 and E1):
• Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
• Lactating females who plan to breastfeed their infants
• Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation
• Note for Group F: patients of childbearing potential should use effective
birth control during treatment with sorafenib and for at least 2 weeks after
stopping treatment
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
This phase III trial investigates how well nivolumab after combined modality therapy works in
treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal
antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may
interfere with the ability of tumor cells to grow and spread.
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have histologically proven
stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0)
invasive squamous cell carcinoma of the anus or anorectum, according to the American
Joint Committee on Cancer (AJCC) 8th edition; this may include tumors of
non-keratinizing histology such as basaloid, transitional cell, or cloacogenic
histology; individuals with squamous cell carcinoma of the anal margin are eligible if
there is evidence of extension of the primary tumor into the anal canal
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have Eastern Cooperative
Oncology Group (ECOG) performance status of 0-2
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have hemoglobin levels of >
9 g/dL (within 2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient must have a platelet count of >
100,000/mm^3 (within 2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient's absolute neutrophil count (ANC)
level must be > 1500/mm^3 (within 2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Serum creatinine must be =< 1.5 X upper
limit of normal (ULN) (within 2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Total bilirubin must be < 2 X ULN (within
2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Aspartate aminotransferase (AST) (serum
glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum
glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
(within 2 weeks prior to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Albumin >= 3.0 g/dL (within 2 weeks prior
to registration)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients known to be human
immunodeficiency virus (HIV)+ are permitted; patients with CD4 > 200 and serum HIV
viral load of < 200 copies/mm^3 are eligible, and in addition:
• Participants must be purified protein derivative (PPD) negative; alternatively,
the QuantiFERON-tuberculosis (TB) Gold In-Tube (QFT-GIT) assay (Cellestis
Limited, Carnegie, Australia) can be used; an individual is considered positive
for M. tuberculosis infection if the IFN-gamma response to TB antigens is above
the test cut-off (after subtracting the background IFN-gamma response in the
negative control); the result must be obtained within 20 weeks prior to
enrollment; PPD positive (or Quantiferon assay positive) participants are
permitted if prophylaxis has been completed prior to enrollment
• No history of acquired immune deficiency syndrome (AIDS)-related complications
within past year other than a history of low CD4+ T-cell count > 200/mm^3 prior
to initiation of combination antiretroviral therapy; on study CD4+ T-cell count
may not be informative due to chemoradiotherapy and should not be used as an
exclusion criterion if low
• Patient must be healthy on the basis of HIV disease with high likelihood of near
normal life span were it not for the anal cancer
• Participants MUST receive appropriate care and treatment for HIV infection,
including antiretroviral medications when clinically indicated, and should be
under the care of a physician experienced in HIV management; participants will be
eligible regardless of antiretroviral medication (including no antiretroviral
medication) provided there is no intention to initiate therapy or the regimen has
been stable for at least 4 weeks with no intention to change the regimen within
12 weeks following enrollment
• Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are
eligible provided stool for ova/parasites and stool cryptosporidium studies are
negative;
• NOTE: HIV testing is not required for eligibility
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: For patients registering prior to start
of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to
registration
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Women of child bearing potential and
sexually active males must use accepted and effective method(s) of contraception
and/or abstain from sexual intercourse while on protocol treatment and for at least 5
months after the last dose of nivolumab (for female patients) and for at least 7
months after the last dose of nivolumab (for male patients)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Any surgery must have been completed >= 4
weeks prior to starting study treatment
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: No uncontrolled intercurrent illness
including, but not limited to ongoing or active infection, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: No prior treatment with an immune
checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal
antibody)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: No patients with immunodeficiency or
receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any
other form of immunosuppressive therapy within 7 days prior to Step 1 registration;
topical corticosteroid or occasional inhaled corticosteroids are allowed
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: No live vaccines within 30 days prior to
registration; examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and
typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed
virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,
Flu-Mist) are live attenuated vaccines and are not allowed
• NOTE: no live vaccines may be administered while participating in the trial
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Previously irradiated patients (Arm S)
must have received radiation per National Comprehensive Cancer Network guidelines;
radiation therapy delivered on protocol (Arm T) will be reviewed
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients will be registered within 63
days following completion of standard chemoradiation for anal cancer; standard
chemoradiation therapy is as defined
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have histologically proven
stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0)
invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th
edition; this may include tumors of non-keratinizing histology such as basaloid,
transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma
of the anal margin are eligible if there is evidence of extension of the primary tumor
into the anal canal
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have received at least 54
gray (Gy) of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region)
for the treatment of the anal cancer
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have ECOG performance
status of 0-2
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have hemoglobin levels of >
10 g/dL (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have a platelet count of >
100,000/mm^3 (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient's ANC level must be > 1500/mm^3
(within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Serum creatinine must be =< 1.5 X ULN
(within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Total bilirubin must be < 2 X ULN (within
2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: AST (SGOT)/ALT (SGPT) =< 2.5 X
institutional upper limit of normal (within 2 weeks prior to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Albumin >= 3.0 g/dL (within 2 weeks prior
to registration)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients known to be human
immunodeficiency virus (HIV)+ patients with CD4 > 200 and serum HIV viral load of <
200 copies/mm^3 are eligible; in addition:
• Participants must be PPD negative; alternatively, the QuantiFERON-TB Gold In-Tube
(QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used; an
individual is considered positive for M. tuberculosis infection if the IFN-gamma
response to TB antigens is above the test cut-off (after subtracting the
background IFN-gamma response in the negative control); the result must be
obtained within 20 weeks prior to enrollment; PPD positive (or Quantiferon assay
positive) participants are permitted if prophylaxis has been completed prior to
enrollment; NOTE: If patient completed chemoradiation on Step 1, PPD testing does
not need to be performed again
• No history of AIDS-related complications within past year other than a history of
low CD4+ T-cell count > 200/mm^3 prior to initiation of combination
antiretroviral therapy; on study CD4+ T-cell count may not be informative due to
chemoradiotherapy should not be used as an exclusion criterion if low
• Patient must be healthy on the basis of HIV disease with high likelihood of near
normal life span were it not for the anal cancer
• Participants MUST receive appropriate care and treatment for HIV infection,
including antiretroviral medications when clinically indicated, and should be
under the care of a physician experienced in HIV management; participants will be
eligible regardless of antiretroviral medication (including no antiretroviral
medication) provided there is no intention to initiate therapy or the regimen has
been stable for at least 4 weeks with no intention to change the regimen within
12 weeks following enrollment
• Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are
eligible provided stool for ova/parasites and stool cryptosporidium studies are
negative)
• NOTE: HIV testing is not required for eligibility
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Scans done within 4 weeks of
randomization to Step 2
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have recovered from all
toxicities associated with chemoradiotherapy for anal cancer, to grade =< 1 with the
exception of alopecia
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Women of child bearing potential and
sexually active males must use accepted and effective method(s) of contraception
and/or abstain from sexual intercourse while on protocol treatment and for at least 5
months after the last dose of nivolumab (for female patients) and for at least 7
months after the last dose of nivolumab (for male patients)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No uncontrolled intercurrent illness
including, but not limited to ongoing or active infection, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No prior treatment with an immune
checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal
antibody)
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No patients with immunodeficiency or
receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
medication; topical corticosteroid or occasional inhaled corticosteroids are allowed
• REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No live vaccines within 30 days prior to
the first dose of trial treatment and while participating in the trial; examples of
live vaccines include, but are not limited to, the following: measles, mumps, rubella,
chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine; seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed; however,
intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are
not allowed
Exclusion Criteria:
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: For patients registering to Arm T,
patients must not have received prior chemoradiotherapy for anal cancer
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients with an allogenic bone
marrow/stem, cell or solid organ transplant are excluded
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Women MUST NOT be pregnant or
breast-feeding due to the potential teratogenic harm or abortifacient effects to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used; all patients must also not expect to conceive or father
children from study registration and throughout their time on study treatment; for
female patients this must continue until at least 5 months after the last dose of
nivolumab and for male patients until at least 7 months after the last dose of
nivolumab; all females of child bearing potential must have a serum or urine pregnancy
test to rule out pregnancy within 2 weeks prior to registration; a female of
childbearing potential is any woman, regardless of sexual orientation or whether they
have undergone tubal ligation, who meets the following criteria: 1) has achieved
menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy,
or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does
not rule out childbearing potential) for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months)
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients will be excluded if they have a
T1 or M1, and T2N0 cancer
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must not have had prior
potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the
anus
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Participants may not be receiving any
other standard anti-cancer therapy or experimental agent concurrently with the study
drugs
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Individuals with a history of a different
malignancy are ineligible except if they have been disease-free for at least 2 years
and are deemed by the investigator to be at low risk for recurrence; individuals with
the following cancers are eligible if diagnosed and treated within the past 5 years:
cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patient must not have active autoimmune
disease in the past 2 years
• NOTE: This does not include patients with autoimmune disease controlled by
medication, such as hypothyroidism; this eligibility includes only patients with
endocrine disease controlled b
Biological: Nivolumab, Other: Patient Observation
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Margin Squamous Cell Carcinoma, Stage IIB Anal Cancer AJCC v8, Stage IIIA Anal Cancer AJCC v8, Stage IIIB Anal Cancer AJCC v8, Stage IIIC Anal Cancer AJCC v8, Stage III Anal Cancer AJCC v8
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (FIDES-01)
This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of
derazantinib by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1
in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors
harbor FGFR2 gene fusions (by FISH performed by the central laboratory) or FGFR2 gene
mutations or amplifications (based on NGS testing performed or commissioned by the respective
study center) and who received at least one prior regimen of systemic therapy. Subjects will
be dosed orally once per day at 300 mg of derazantinib capsules.
1. Signed written informed consent granted prior to initiation of any study-specific
procedures
2. 18 years of age or older
3. Histologically or cytologically confirmed locally advanced, inoperable (where surgery
is not indicated due to disease extension, co-morbidities, or other technical
reasons), or metastatic iCCA or mixed histology tumors (combined
hepatocellular-cholangiocarcinoma [cHCC-CCA])
4. Substudy 1: FGFR2 gene fusion status based on the following assessments:
a) If central laboratory designated by Sponsor: Positive FISH test; and/or b) If
non-central laboratory: i) Positive FISH or NGS test: patients may be enrolled and may
start dosing, but central confirmation is required* ii) Negative FISH or NGS test:
tissue may be submitted to the central laboratory designated by the Sponsor, and
patients may only be enrolled if the central test is positive
*Using standard protocols and approved by local IRB/EC, by CLIA or other similar
agency.
Substudy 2: FGFR2 mutation/amplification status based on local NGS testing performed
or commissioned by the respective study site.
5. Received at least one regimen of prior systemic therapy and then experienced
documented radiographic progression
6. Measurable disease by RECIST version 1.1 criteria
7. ECOG performance status ≤ 1
8. Adequate organ functions as indicated by the following laboratory values (based on
screening visit values from the central laboratory).
• Hematological
• Hemoglobin (Hgb) ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
• Platelet count ≥ 75 x 109/L
• International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤
3 for subjects receiving anticoagulant therapy such as Coumadin or heparin
• Hepatic
• Total bilirubin ≤ 2 x ULN
• AST and ALT ≤ 3 ULN (≤ 5 x ULN for subjects with liver metastases)
• Albumin ≥ 2.8 g/dL
• Renal
• Serum creatinine ≤ 1.5 x ULN
• Creatinine clearance of ≥ 30 mL/min as estimated by the Cockcroft-Gault
equation
9. Female and male patients of child-producing potential must agree to avoid becoming
pregnant or impregnating a partner, respectively, use double-barrier contraceptive
measures, oral contraception, or avoidance of intercourse, during the study*, and
until at least 120 for 90 days after the last dose of derazantinib.
*From the day of first study medication, or for oral contraception from 14 days before
first study medication.
Male patients are considered not to be of child-producing potential if they have
azoospermia (whether due to vasectomy or an underlying medical condition). Female
patients are considered not to be of child-producing potential if they are:
• postmenopausal* , or
• have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or
bilateral tubal ligation/occlusion, at least 6 weeks prior to screening, or
• have a congenital or acquired condition that prevents childbearing.
Male or female patients of child-producing potential must agree to comply with one of
the following until at least 120 days after the last dose of derazantinib:
1. Abstinence from heterosexual activity**
2. Using (or having their partner use) an acceptable method of contraception during
heterosexual activity. Acceptable methods of contraception are***:
• any ONE of:
•an intrauterine device (IUD)
•vasectomy of a female patient's male partner
•a contraceptive rod implanted into the skin.
• any TWO in combination of:
•diaphragm with spermicide (cannot be used in conjunction with cervical
cap/spermicide)
•cervical cap with spermicide (nulliparous women only)
•contraceptive sponge (nulliparous women only)
•male condom or female condom (cannot be used together)
•hormonal contraceptive (oral contraceptive pill [estrogen/progestin pill
or progestin-only pill], contraceptive skin patch, vaginal contraceptive
ring, or subcutaneous contraceptive injection)
*Postmenopausal is defined as at least 12 months with no menses without an
alternative medical cause; in women < 45 years of age a high follicle
stimulating hormone (FSH) level in the postmenopausal range may be used to
confirm a post -menopausal state in women not using hormonal contraception
or hormonal replacement therapy. In the absence of 12 months of amenorrhea,
a single FSH measurement is not sufficient.
• Abstinence (relative to heterosexual activity) can be used as the sole
method of contraception if it is consistently employed as the subject's
preferred and usual lifestyle and if considered acceptable by local
regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar,
ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal
are not acceptable methods of contraception.
• If a contraceptive method listed above is restricted by local
regulations/guidelines, then it does not qualify as an acceptable
method of contraception for subjects participating at sites in
this country/region.
Exclusion Criteria:
1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an
interval shorter than the following, as applicable:
• One chemotherapy or biological (e.g., antibody) cycle interval
• Five half-lives of any small-molecule investigational or licensed medicinal
product
• Two weeks, for any investigational medicinal product with an unknown half-life
• Four weeks of curative radiotherapy
• Seven days of palliative radiotherapy
• 28 days of radiotherapy
2. Major surgery, locoregional therapy, or radiation therapy within four weeks of the
first dose of derazantinib
3. Previous treatment with any FGFR inhibitor (e.g., Balversa® [erdafitinib], Pemazyre®
[pemigatinib], infigratinib, rogaratinib, futibatinib, lenvatinib, ponatinib,
dovitinib, nintedanib, AZD4547, LY2784455).
•Subjects who received less than four weeks of therapy and were unable to continue
therapy due to toxicity will be allowed to participate
4. Unable or unwilling to swallow the complete daily dose of derazantinib capsules
5. Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects
must have stable disease ≥ 3 months, confirmed by magnetic resonance imaging (MRI) or
computed tomography (CT) scan, and/or have CNS metastases well controlled by low-dose
steroids, anti-epileptics, or other symptom-relieving medications)
6. Current evidence of clinically significant corneal or retinal disorder likely to
increase the risk of eye toxicity, including but not limited to bullous/band
keratopathy, keratoconjunctivitis (unless keratoconjunctivitis sicca), corneal
abrasion, inflammation/ulceration, confirmed by ophthalmologic examination.
7. Concurrent uncontrolled or active hepatobiliary disorders, untreated or ongoing
complications after laparoscopic procedures or stent placement, including but not
limited to active cholangitis, biloma or abscess (to be eligible, the subjects have to
be treated and disorders/complications should be resolved within 2 weeks prior to the
first dose of derazantinib)
8. History of significant cardiac disorders:
• Myocardial infarction (MI) or congestive heart failure defined as Class II to IV
per the New York Heart Association (NYHA) classification within 6 months of the
first dose of derazantinib (MI that occurred > 6 months prior to the first dose
of derazantinib will be permitted)
• QTcF >450 msec (males or females)
9. Serum electrolyte abnormalities defined as follows:
•Hyperphosphataemia: Serum phosphate > institutional ULN
•Hyperkalemia: > 6.0 mmol/L
•Hypokalemia: < 3.0 mmol/L
•Hypercalcemia: corrected serum calcium < 1.75 mmol/L (< 7.0 mg/dL)
• Hypocalcemia: corrected serum calcium > 3.1 mmol/L (> 12.5 mg/dL)
• Hypomagnesemia: < 0.4 mmol/L (< 0.9 mg/dL)
10. Significant gastrointestinal disorder(s) that could, in the opinion of the
Investigator, interfere with the absorption, metabolism, or excretion of derazantinib
(e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
11. History of additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin that has undergone potentially curative therapy, and in situ cervical cancer.
12. Concurrent uncontrolled illness not related to cancer, including but not limited to:
• Psychiatric illness/substance abuse/social situation that would limit compliance
with study requirements
• Known uncontrolled human immunodeficiency virus (HIV) infection
• Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral
or IV medication at the time of first dose of study drug administration
13. Blood or albumin transfusion within 5 days of the blood draw being used to confirm
eligibility
14. Pregnant or breast feeding
15. Known hypsersensitivity to derazantinib, or to any of the study drug excipients
(starch, lactose, crospovidone, magnesium stearate)
Drug: derazantinib
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma, Liver
iCCA, intrahepatic cholangiocarcinoma, FGFR2 gene fusion or FGFR2 gene mutation or amplification, biliary cancer, bile duct cancer, FGFR2 gene rearrangement, liver cancer, targeted therapy, combined hepatocellular and cholangiocarcinoma, cHCC-CCA, derazantinib
A Study of Tivozanib in Combination With Durvalumab in Subjects With Untreated Advanced Hepatocellular Carcinoma (DEDUCTIVE)
This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor
activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
1. ≥ 18 years old
2. Signed and dated written informed consent
3. Untreated histologically or cytologically confirmed unresectable locally advanced or
metastatic hepatocellular carcinoma. Measurable or evaluable disease by RECIST 1.1
criteria.
4. Child-Pugh Class A.
5. ECOG performance status ≤ 1 and life expectancy ≥ 3 months.
6. Body weight > 30 kg
7. Measured creatinine clearance (crCL) >40 mL/min or calculated crCL >40 mL/min as
determined by Cockcroft-Gault (using actual body weight) Males CrCL = Weight (kg) ×
(140 •Age) 72 × serum creatinine (mg/dL) Females CrCL = Weight (kg) × (140 •Age) 85
× serum creatinine (mg/dL)
8. Sexually active pre-menopausal female subjects (and female partners of male subjects)
must use highly effective contraceptive measures, while on study and for at least 90
days after the last dose of study drug. Sexually active male subjects must use
adequate contraceptive measures, while on study and for at least 90 days after the
last dose of study drug. All fertile male and female subjects and their partners must
agree to use a highly effective method of contraception.
Exclusion Criteria:
1. Subjects who have received prior systemic treatment for HCC
2. Female subjects who are pregnant or breastfeeding or male or female subjects of
reproductive potential who are not willing to employ effective birth control from
screening to 90 days after the last dose of study drug.
3. Brain metastases or spinal cord compression. Subjects with suspected brain metastases
at screening should have an MRI (preferred) or CT scan each preferable with IV
contrast of the brain prior to study entry. Brain metastases will not be recorded on
RECIST Target Lesions at baseline.
4. Any of the following hematologic abnormalities:
• Hemoglobin < 9.0 g/dL
• Absolute neutrophil count (ANC) < 1500 per mm3
• Platelet count < 75,000 per mm3
5. Any of the following serum chemistry or urinalysis abnormalities:
• Total bilirubin > 2 × ULN (>2.5 mg/dL in subjects with Gilbert's syndrome)
• AST or ALT > 5 × ULN
• Alkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone
metastasis)
• Serum creatinine > 1.5 × ULN
• > 2+ proteinuria
6. History of hepatic encephalopathy within past 12 months or requirement for medications
to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for
purposes of hepatic encephalopathy).
7. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months. (Note: For
patients with a history of GI bleeding for more than 12 months or assessed as high
risk for esophageal variceal bleed by the Investigator, adequate endoscopic therapy
according to institutional standards is required).
8. Clinically meaningful ascites defined as ascites requiring non-pharmacologic
intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior
to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥ 2
months are eligible.
9. Main portal vein thrombosis (Vp4) as documented on imaging. (VP4 is defined as portal
vein thrombosis in the main trunk of the portal vein or a portal vein branch
contralateral to the primarily involved lobe (or both).
10. For subjects who require ongoing therapeutic anti-coagulation or anti-platelet
therapy; the subject must be off either therapy for at least 7 days prior to the first
dose of investigational product. Low-dose aspirin for cardiac prophylaxis/protection
is permitted per local institutional standards.
11. Patients co-infected with HBV and HCV. HBV positive [presence of hepatitis B surface
antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV
DNA (≥10IU/ml)]; HCV positive (presence of anti-HCV antibodies).
12. Major surgery (as defined by the investigator) within 28 days prior to first dose of
IP or still recovering from prior surgery. Local procedures (eg, core needle biopsy,
and prostate biopsy) are allowed if completed at least 3 days prior to the
administration of the first dose of study treatment.
13. Significant cardiovascular disease, including:
• Clinically symptomatic heart failure. Subjects with a history of heart failure
must have an ECHO or MUGA scan to document left ventricular ejection fraction
(LVEF) > 45% prior to start of protocol therapy
• Any New York Heart Association classification ≥ Class 2 (prefer Class 0 or 1)
• Any stenting procedure within the last 3 months
• Venous thromboembolism or arterial thromboembolism within the last 3 months
• Any IVC tumor thrombosis
• History of a hemorrhagic event (i.e., GI bleed within 6 months)
• Uncontrolled hypertension: blood pressure >150/95 mmHg on more than 2
antihypertensive medications, on two consecutive measurements obtained at least
24 hours apart. Subjects with a history of hypertension must have been on stable
doses of anti-hypertensive drugs for ≥ 2 weeks prior to start of protocol
therapy.
• Myocardial infarction within 3 months prior to start of protocol therapy
14. Subjects with delayed healing of wounds, ulcers, and/or bone fractures
15. Serious/active infection or infection requiring parenteral antibiotics
16. Inadequate recovery from any prior surgical procedure; major surgical procedure within
4 weeks prior to start of protocol therapy.
17. Inability to comply with protocol requirements
18. History of another primary malignancy except for:
• Malignancy treated with curative intent and with no known active disease ≥ 5
years before the first dose of study drug and low potential risk for recurrence
• Adequately treated non-melanoma skin cancer of lentigo maligna without evidence
of disease
19. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and tuberculosis testing in
line with local practice), , hepatitis C, or human immunodeficiency virus (positive
HIV 1/2 antibodies). Subjects positive for hepatitis C (HCV) antibody are eligible
only if polymerase chain reaction is negative for HCV RNA.
20. Patients with a history or current HBV infection (detectable HBV DNA), should be
placed on anti-viral treatment and tested at every cycle for HBV DNA viral load.
21. Treatment with systemic hormonal therapy within 3 weeks prior to start of protocol
therapy, with the exception of:
• Hormonal therapy for appetite stimulation or contraception
• Nasal, ophthalmic, inhaled and topical steroid preparations
• Oral replacement therapy for adrenal insufficiency
• Low-dose maintenance steroid therapy (equivalent of prednisone 10mg/day) for
other conditions
• Hormone replacement therapy such as testosterone
22. Strong CYP3A4 inducers within 2 weeks prior to start of, or during, protocol therapy.
23. Prior exposure to tivozanib or any checkpoint inhibitor
24. History of allogeneic organ transplantation
25. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with
the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,
or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid
arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this
criterion:
• Subjects with vitiligo or alopecia
• Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Subjects without active disease in the last 5 years may be included but only
after consultation with Medical Monitor
• Subjects with celiac disease controlled by diet alone
26. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease,
serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric
illness/social situations that would limit compliance with study requirement,
substantially increase risk of incurring AEs or compromise the ability of the subject
to give written informed consent
27. History of leptomeningeal carcinomatosis
28. History of active primary immunodeficiency
29. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms
calculated from 3 ECGs (within 15 minutes at 5 minutes apart
30. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients
31. Concurrent enrolment in another clinical study, unless it is an observational (non
interventional) clinical study or during the follow-up period of an interventional
study
32. Receipt of live attenuated vaccine within 30 days prior to the first dose of study
drug. Note: Subjects, if enrolled, should not receive live vaccine whilst receiving
study drug and up to 30 days after the last dose of study drug.
33. Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication)
34. Previous study drug assignment in the present study
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design (ASPIRe)
The study is a multi-center, randomized, surgical trial of women with symptomatic
post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare
the three available surgical treatments performed in usual practice. The purpose of this
study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical
Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The
primary outcome is measured over time (up to 60 months) using a survival analysis approach.
The investigators hypothesize that treatment failure will not differ between vaginally and
abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of
implantation) will be superior to native tissue apical suspension.
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Rahn
49553
Female
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02676973
STU 042016-010
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Women age 21 or older
2. Prior total hysterectomy (no cervix present)
3. Prolapse beyond the hymen (defined as Ba, C, or Bp > 0 cm)
4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as
point C> -2/3 TVL)
5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to
'sensation of bulging' or 'something falling out'
6. Desires surgical treatment for post-hysterectomy vaginal prolapse
7. Available for up to 60 month follow-up
Exclusion Criteria:
1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to
augment POP repair including anterior, posterior and/or apical compartments
2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy
vaginal vault prolapse *
3. Known adverse reaction to synthetic mesh or biological grafts; these complications
include but are not limited to erosion, fistula, or abscess
4. Unresolved chronic pelvic pain-active
5. Prior abdominal or pelvic radiation
6. Contraindication to any of the index surgical procedures
• Known Horseshoe Kidney or Pelvic Mass overlying the sacrum
• Active diverticular abscess or active diverticulitis
• Shortened vaginal length (<6 cm TVL)
• NOTE:
• Only documented SSLS will be an exclusion.
• Mesh used for only mid-urethral sling will NOT be an exclusion
• If prior POP repair is unknown and unable to be documented, subjects
will be eligible based on clinician judgment. The investigator will
examine and assess for evidence of mesh or graft if no evidence of mesh
or graft is present on examination subject remains eligible.
Procedure: Open, Robotic, or Laparoscopic, Procedure: Transvaginal Native Tissue Repair, Procedure: Uphold™ LITE
AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)
for the treatment of liver fibrosis in adult subjects with NASH.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Lafaine Grant
95467
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03028740
STU 062017-106
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Inclusion Criteria:
• Male and female subjects aged between 18-75 years
• Ability to understand and sign a written informed consent form (ICF)
• Histological evidence of NASH based on central reading of the Screening biopsy
• Subjects included in Part1 must have histopathological evidence of Stage 2 or 3 liver
fibrosis per the NASH CRN System based on central reading of the Screening biopsy
slides. Subjects newly randomized in Part 2 must have histological evidence of Stage 3
liver fibrosis per the NASH CRN System, based on central reading of the Screening
period biopsy slides. Historical biopsy can be used, provided the criteria listed on
Item 3a above are fulfilled.
• Females of childbearing potential and males participating in the study must agree to
use at least 2 approved methods of contraception throughout the duration of the study
and for 30 days after stopping study drug. Females who are postmenopausal must have
documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating
hormone (FSH) ≥ 30 mU/mL at Screening.
Exclusion Criteria:
• Inability to undergo a liver biopsy
• Hepatitis B surface antigen (HBsAg) positive
• Hepatitis C antibody (HCVAb) positive
• Human immunodeficiency virus (HIV)-1 or HIV-2 infection
• Prior or planned liver transplantation
• Other known causes of chronic liver disease
• History or presence of cirrhosis and/or hepatic decompensation including ascites,
hepatic encephalopathy or variceal bleeding
• Alcohol consumption greater than 21 units/week for males or 14 units/week for females
• AST > 200 IU/L in males and females at Screening
• ALT > 250 IU/L in males and > 200 IU/L in females at Screening
• HbA1c > 10% at Screening
• Serum albumin < 3.5 g/dL at Screening
• Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the
Modification of Diet in Renal Disease (MDRD) equation
• Platelet count < 100,000/mm3
• Total bilirubin > 1.5 mg/dL
• International normalized ratio (INR) > 1.3
• Model of end stage liver disease (MELD) score > 12
• Weight reduction, defined as ≥ 7% of body weight, through bariatric surgery in the
past 5 years or bariatric surgery planned during the conduct of the study (including
gastric banding and sleeve surgery)
• History of malignancy within the past 5 years or ongoing malignancy other than basal
cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
• Active, serious infections that require parenteral antibiotic or antifungal therapy
within 30 days prior to Screening Visit
• Clinically significant cardiovascular or cerebrovascular disease within the past 3
months
• Females who are pregnant or breastfeeding
• Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic
agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine,
tacrolimus) except for vaccines or short-term corticosteroids
• Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4
(DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or SGLT1 inhibitor, or
a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver
biopsy. Subjects on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor,
SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening
liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to
be used, subjects need to be on stable therapy for at least 6 months prior to the day
historical liver biopsy was performed).
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 (JUNIPER)
This open-label extension and safety monitoring study is composed of two parts: Part 1 will
evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants
with moderately to severely active Crohn's disease who were previously enrolled in the
etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for
enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment
(either by exiting Part 1 of this study or by entering directly from Study GA29144
[NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy
(PML) and other safety events.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Moheb Boktor
184157
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02403323
STU 102017-058
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Inclusion Criteria:
Part 1 Open-Label Extension:
• Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who
meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
• Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are
not eligible or choose not to enter Part 1
• Patients who transfer from Part 1
• Completion of the 12-week safety follow-up period prior to entering
Exclusion Criteria:
Part 1 Open-Label Extension:
• Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
• No exclusion criteria
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
daily versus placebo in subjects with non-alcoholic steatohepatitis
Call 214-648-5005 studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02970942
STU-2019-0799
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Inclusion Criteria:
• Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial except for protocol described
pre-screening activities which require a separate informed consent.
• Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged
20-75 years (both inclusive)) at the time of signing informed consent
• Local histological diagnosis of NASH followed by histological confirmation of NASH
based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks
before screening
• Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy
obtained up to 21 weeks before screening.
• NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based
on central pathologist evaluation
Exclusion Criteria:
• Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for
men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders
Identification Test (AUDIT questionnaire))
• Diagnosis of type 1 diabetes according to medical records
• HbA1c above 10% at screening
• History or presence of pancreatitis (acute or chronic)
• Calcitonin equal or above 50 ng/L at screening
• Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative
• Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1)
• Female who is pregnant, breast-feeding or intends to become pregnant or is of
childbearing potential and not using an adequate contraceptive method (adequate
contraceptive measures as required by local regulation or practice)
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary
efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in
subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including
bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant
prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer
(TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric
cancer and gastroesophageal junction cancer (GC/GEJC), colorectal cancer (CRC), head and neck
(H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in
the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination
with standard dosing regimen of atezolizumab will be established; in the Expansion Stage,
tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy
of the combination treatment in these tumor indications. Two exploratory single-agent
cabozantinib (SAC) cohorts will also be enrolled with UC or NSCLC subjects.
1. Cytologically or histologically and radiologically confirmed solid tumor that is
inoperable, locally advanced, metastatic, or recurrent:
• Dose-Escalation Stage:
• Subjects with UC (including renal pelvis, ureter, bladder, urethra) after
prior platinum-based therapy, or
• Subjects with RCC (clear cell, non-clear cell histology) with or without
prior systemic anticancer therapy
• Expansion Stage:
• Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC,
TNBC, OC, EC, HCC, GC/GEJC, CRC, H&N cancer, and DTC as outlined above)
2. Measurable disease per RECIST 1.1 as determined by the investigator.
3. Tumor tissue material available (archival or recent tumor biopsy)
4. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior
treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive
therapy.
5. Age eighteen years or older on the day of consent.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ and marrow function.
8. Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception.
9. Female subjects of childbearing potential must not be pregnant at screening.
Exclusion Criteria:
1. Prior treatment with cabozantinib or immune checkpoint inhibitors including
anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts
5, 7,19 and 20. Other restrictions regarding prior therapy may apply.
2. Known brain metastases or cranial epidural disease unless adequately treated and
stable for at least 4 weeks before first dose of study treatment.
3. Concomitant anticoagulation with oral anticoagulants.
4. Subject is receiving systemic steroid therapy or any other form of immunosuppressive
therapy within 2 weeks prior to first dose of study treatment.
5. Administration of a live, attenuated vaccine within 30 days before first dose of study
treatment.
6. The subject has uncontrolled, significant intercurrent or recent illness, including,
but not limited to, an active or history of autoimmune disease or immune deficiency;
idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection
requiring systemic treatment, infection with human immunodeficiency virus (HIV),
AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for
tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
7. Pregnant or lactating females.
8. Previously identified allergy or hypersensitivity to components of the study treatment
formulations.
9. Diagnosis of another malignancy within 2 years before first dose of study treatment.
1. Have histologically confirmed advanced or metastatic castration-resistant prostate
cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer,
colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck
squamous cell carcinoma.
Or,
Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent
unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
2. Have not received any approved chemotherapy, except in the adjuvant setting.
Exclusion Criteria:
1. Subject was using immunosuppressive medications within 14 days before Screening with
the exception of topical (intranasal, inhaled, and local injection), systemic
(prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions
such as computed tomography (CT) scan premedication.
2. Subject has active infections or other serious underlying significant medical illness,
abnormal and clinically significant laboratory findings or psychiatric illness/social
situation.
3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator,
cochlear implants, cochlear implants, or other electronic medical equipment.
4. Subject has documented immunodeficiency or organ transplant.
5. Subject has an untreated central nervous system disease, leptomeningeal disease or
cord compression.
6. Subject has a history, or presence, of significant cardiovascular diseases; including
uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or
myocardial infarction within 6 months before randomization, congestive heart failure >
New York Heart Association Class II, severe peripheral vascular disease, corrected QT
(QTc) prolongation >470 msec, clinically significant pericardial effusion.
7. Subject has a history or presence of documented inflammatory bowel disease.
8. Subject is known to be positive for human immunodeficiency virus infection.
-
Linerixibat Long-term Safety and Tolerability Study
This is an open-label, non-comparator, global, multi-center, long-term safety study for
evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus
in primary biliary cholangitis (PBC) who participated in a prior eligible clinical trial with
linerixibat. Participants will be administered with 90 milligrams (mg) linerixibat orally
twice daily. The total daily dose will not exceed 180 mg total daily dose. The effect of
linerixibat on measures of quality of life and health-related quality of life in the study
population will also be assessed. The duration of the study will be approximately four years
until study end and the total duration of study participation will vary by participant
depending upon time of entry relative to study end in their respective country. Approximately
75 participants will be enrolled in this study.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Marlyn Mayo
14698
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04167358
STU-2020-0186
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Inclusion Criteria:
• Participant must be 18 to 80 years of age inclusive, at the time of signing the
informed consent in the participant's parent trial BAT117213 (NCT01899703) or 201000
(NCT02966834)
• Participants with a diagnosis of PBC and a history of associated pruritus as evidenced
by randomization into a prior eligible linerixibat clinical trial.
• Participants must have completed the main treatment period in a prior eligible
linerixibat clinical trial.
• Male or female; Contraceptive use by women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Contraception by male participants or male partners of female participants is not
required in this protocol.
• A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies:
1. is not a woman of childbearing potential (WOCBP) or
2. is a WOCBP and using a contraceptive method that is highly effective (with a
failure rate of <1 percent [%] per year), with low user dependency, as described
during the intervention period and for at least 4 weeks, after the last dose of
study intervention. The investigator should evaluate the effectiveness of the
contraceptive method in relationship to the first dose of study intervention;
3. a WOCBP must have a negative highly sensitive pregnancy test (urine or serum as
required by local regulations) within 24 hours before the first dose of study
intervention;
4. if a urine test cannot be confirmed as negative (e.g., an ambiguous result), a
serum pregnancy test is required. In such cases, the participant must be excluded
from participation if the serum pregnancy result is positive.
5. The investigator is responsible for review of medical history, menstrual history,
and recent sexual activity to decrease the risk for inclusion of a woman with an
early undetected pregnancy.
• Capable of giving signed informed consent as described in which includes compliance
with the requirements and restrictions listed in the informed consent form (ICF) and
in this protocol.
Exclusion Criteria:
• Screening total bilirubin >2x upper limit of normal (ULN). Total bilirubin >2x ULN is
acceptable if bilirubin is fractionated and direct bilirubin <35%.
• Screening ALT or AST >6x ULN.
• Screening eGFR <45 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based
on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy
or ascites).
• Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection and/or
confirmed hepatocellular carcinoma or biliary cancer.
• Recent or current clinically significant diarrhea in the Investigator's medical
opinion.
• Current symptomatic cholelithiasis or inflammatory gallbladder disease is
exclusionary. Participants with history of cholecystectomy >=3 months before screening
may be eligible for enrollment.
• Current diagnosis or previous diagnosis of colorectal cancer.
• Any current medical condition (e.g. psychiatric disorder, senility or dementia), which
may affect the participant's ability to comply with the protocol specified procedures.
• Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and
may not restart until after the end of the study or study withdrawal.
• Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1
month prior to screening.
• Current enrollment or participation in any other clinical study (except for 201000)
involving an investigational study treatment within 8 weeks prior to the screening
visit.
• QT interval corrected (QTc) >480 millisecond (msec): A QTc >480 msec (12-lead
electrocardiogram [ECG]) at screening is exclusionary.
• History of regular alcohol consumption within 6 months of the study defined as an
average weekly intake of >21 units for males or >14 units for females. One unit is
equivalent to 8 grams (g) of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1
glass (125 mL) of wine or 1 measure (25 mL) of spirits.
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer
that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as
fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively)
may work better in treating patients with pancreatic cancer compared to giving chemotherapy
after surgery (adjuvantly).
PRE-REGISTRATION:
• Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous
carcinoma
• TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes
and organs)
• Resectable Primary Tumor: Local radiographic reading must be consistent with
resectable disease defined as the following on 1) arterial and venous phase
contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance
imaging (MRI) scan and 2) chest CT:
• No involvement or abutment of the celiac artery, common hepatic artery, superior
mesenteric artery, or replaced right hepatic artery (if applicable)
• Less than 180 degree interface between tumor and vessel wall of the portal vein
or superior mesenteric vein, and patent portal vein/splenic vein confluence
• No evidence of metastatic disease
• Measurable disease or non-measurable disease o Non-measurable disease is defined as
cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by
fine needle aspiration or core-biopsy of the pancreas without measurable disease by
radiographic imaging
REGISTRATION:
• Confirmation of resectable disease by real-time central imaging review by the Alliance
Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
• Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon
intending to perform the resection
• No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy,
or surgery for pancreatic cancer
• Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic, and teratogenic effects.
• Therefore, for women of childbearing potential only, a negative pregnancy test done =<
14 days prior to registration is required
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Total Neuropathy Score < 2
• Absolute neutrophil count (ANC) >= 1,500/uL
• Platelet count >= 100,000/uL
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is
present, then biliary drainage must be initiated and total bilirubin =< 3.0)
• Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min
(Calculated using the Cockcroft-Gault equation)
• No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
• No comorbid conditions that would prohibit curative-intent pancreatectomy
• Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this
study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to
registration
• Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this
study. Patients on strong CYP3A4 inducers must discontinue the drug prior to
registration
Stereotactic Radiosurgery (SRS) for Brain Metastasis (SRS)
SRS dose escalation for brain metastases in radiation-naïve patients will establish true
tolerable doses, which may exceed the current standard doses. This may lead to an improvement
in local control, patient survival, and/or quality-of life.
Inclusion Criteria
1. Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ
cell cancer, or unknown primary tumor.
2. Radiographic evidence by MRI (or by CT scan with CT contrast if ineligible or
intolerant of MRI) of brain metastasis. (If patient is unable to tolerate MRI
contrast, an MRI without contrast is acceptable if lesions are visible)
3. All brain metastases must be outside the brain stem (midbrain, pons and medulla).
4. Patient must have 10 or less brain metastases.
5. The maximum diameter of any lesion must be less than or equal to 3.0 cm.
6. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any
targeted agents are allowed provided that:
• Radiation was not to the brain.
• Surgery to the brain was > 7 days prior to SRS and there remains at least one
additional brain metastasis that can be targeted with SRS
7. Age ≥ 18 years.
8. ECOG Performance Score of 2 or better/Karnofsky Performance Status score of 50-60 or
better.
9. All men, as well as women of child-bearing potential must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately.
10. A female of child-bearing potential is any woman (regardless of sexual orientation,
having undergone a tubal ligation, or remaining celibate by choice) who meets the
following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months).
11. Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
1. Patients had craniotomy and surgery to the brain within 7 days from the date of SRS.
2. Patients with leptomeningeal metastasis.
NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive
CSF cytology and/or equivocal radiologic or clinical evidence of leptomeningeal
involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal
enhancement by imaging (MRI) would be considered to have LMD even in the absence of
positive CSF cytology, unless a parenchymal lesion can adequately explain the
neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally
symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would
not be considered to have LMD. In that patient, CSF sampling is not required to
formally exclude LMD, but can be performed at the investigator's discretion based on
level of clinical suspicion.
3. Patients with a contraindication to both MRI (with or without contrast) and CT scan
(with contrast)
4. Patients with life expectancy < 3 months.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that, in the opinion of the
investigator, would limit compliance with study requirements.
6. Subjects must not be pregnant or nursing at the time of SRS treatment due to the
potential for congenital abnormalities and the potential of this regimen to harm
nursing infants.
Radiation: Stereotactic Radiosurgery
Brain Neoplasms, Adult, Malignant, Lymphoma, Sarcoma, Multiple Myeloma, Brain and Nervous System, Other, Eye and Orbit, Anklylosing Spondylitis, Anus, Bones and Joints, Breast - Female, Breast - Male, Cardiovascular, Cervix, Colon, Corpus Uteri, Ear, Esophagus, Gall Bladder, Head and Neck, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Nose, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Throat, Thyroid, Urinary Bladder, Uterine (Endometrial), Vulva, Hodgkins Lymphoma, Lymphoid Leukemia, Small Intestine, Soft Tissue
FARE Peanut SLIT and Early Tolerance Induction (FARE/SLIT)
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in
subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this
objective will be a statistically significant difference in challenge scores between the
treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food
challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are
measured by the amount of peanut protein participants are able to ingest successfully without
symptoms of an allergic reaction. [Time Frame: Baseline, 36 months]
Secondary Objectives:
A secondary outcome of this objective will be a statistically significant difference in the
challenge score of the treatment group versus the placebo group during the DBPCFC performed 3
months after discontinuing therapy (tolerance).
To examine the change in immune parameters associated with peanut SLIT and the development of
clinical tolerance. Through this objective, the investigators will seek to understand the
molecular processes by which SLIT affects the immune system through evaluation of immune
mechanisms in relationship to clinical findings of desensitization and tolerance. The
investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral
responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4 response, 2) peanut
specific basophil activation, 3) mast cell responses through skin prick testing, and 4)
specific T-cell cytokine responses and T regulatory cell (TReg) activation. The investigators
anticipate that the effect of peanut SLIT will occur by induction of TRegs, conversion of T
cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response (measured by
cytokines, antibody levels, and skin prick test size), a change in peanut-specific basophil
activation, or through a combination of the above.
[Time Frame: Baseline, 39 months]
Call 214-648-5005 studyfinder@utsouthwestern.edu
John Bird
108478
All
12 Months to 48 Months old
Phase 2
This study is NOT accepting healthy volunteers
NCT02304991
STU 022014-047
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Inclusion Criteria:
• Written informed consent from participant's parent/guardian.
• Age 12-48 months of either sex, any race, any ethnicity.
• A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a
serum peanut-specific IgE [UniCAP] > 0.35 kUA/L AND a positive skin prick test to
peanut (>3 mm than the negative control) OR are sensitized to peanut (based on a serum
IgE [UniCAP] to peanut of > 5 kUA/L) AND a positive skin prick test to peanut (> 3 mm
than the negative control) and no known history of ingestion of peanut.
• A positive DBPCFC to 1000 mg of peanut at enrollment.
Exclusion Criteria:
• History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or
neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion,
collapse or loss of consciousness).
• Participation in any interventional study for the treatment of food allergy in the
past 6 months.
• Known oat, wheat, or glycerin allergy.
• Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.
• Severe asthma (2007 NHLBI Criteria Steps 5 or 6 •Appendix 2).
• Inability to discontinue antihistamines for skin testing and DBPCFCs.
• Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic
therapy within the past year.
• Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
angiotensin-receptor blockers (ARB) or calcium channel blockers.
• Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular,
hematologic, or pulmonary disease) which would make the subject unsuitable for
induction of food reactions.
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective
in treatment of moderate to severe ulcerative colitis.
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Fudman
95363
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02958865
STU 062017-038
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Inclusion Criteria:
• Diagnosis of ulcerative colitis for greater than/equal to 3 months.
• Moderate to severe active ulcerative colitis
• Inadequate response to, loss of response to, or intolerance to at least one
conventional therapy for UC.
Exclusion Criteria:
• Pregnant or breastfeeding
• Clinical findings suggestive of Crohn's Disease
• History of bowel surgery within 6 months
Drug: PF-06651600 or Placebo, Drug: PF-06700841 or Placebo, Drug: PF-06700841, Drug: PF-06651600