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99 Study Matches

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors

Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in patients with Advanced Solid Tumors
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Kevin Courtney
131906
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT02667873
STU 032016-072
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Inclusion Criteria:

• The patient must have histologic or cytologic evidence of a malignant solid tumor and must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit.
• The patient must have advanced disease, defined as cancer that is either metastatic, OR locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
• The patient must have disease that is measurable by standard imaging techniques, per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or evaluable per RECIST 1.1. (For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field[s], unless disease progression has been documented at that disease site subsequent to radiation.)
• The patient is ≥18 years old.
• The patient has an ECOG PS of 0-2.
• The patient has adequate baseline organ function, as demonstrated by the following:
• Serum creatinine ≤1.5 × institutional upper limit of normal (ULN) or calculated creatinine clearance >30 mL/min.
• Serum albumin ≥2.5 g/dL.
• Bilirubin ≤1.5 × institutional ULN.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN (patients with hepatic metastases must have AST/ALT ≤5 times ULN).
• International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤1.5 × ULN.
• The patient has adequate baseline hematologic function, as demonstrated by the following:
• Absolute neutrophil count (ANC) ≥1.5×10⁹/L
• Hemoglobin ≥8 g/dL, with no red blood cell (RBC) transfusions within the prior 14 days.
• Platelet count ≥100×10⁹/L, with no platelet transfusions within the prior 14 days.
• If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
• The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 1 month after the last dose of SL-801.
• The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
• The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.
Exclusion Criteria:

• The patient has persistent clinically significant ≥Grade 2 toxicities from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
• The patient has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 28 days prior to study entry (Patients with advanced prostate cancer who are receiving luteinizing hormone releasing hormone [LHRH] agonists are permitted onto the study and should continue use of these agents during study treatment).
• The patient has received treatment with an investigational systemic anticancer agent within 28 days prior to C1D1.
• The patient has previously received treatment with SL-801 or another investigational agent that inhibits the XPO1/CRM1 pathway.
• The patient has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia), organ-confined prostate cancer with no evidence of progressive disease.
• The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure [Appendix 1], uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
• The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's opinion, would put the patient at significant risk for pulmonary complications during the study.
• The patient has known active or suspected brain or leptomeningeal metastases. (Central nervous system [CNS] imaging is not required prior to study entry unless there is a clinical suspicion of CNS involvement). Patients with stable, treated brain metastases are eligible provided there is no evidence of CNS disease growth on imaging for at least 3 months following radiation therapy or other locoregional ablative therapy to the CNS.
• The patient is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell) or management of immune-mediated toxicities due to immunotherapy. Low-dose corticosteroid (defined as < 10mg/day of prednisone or equivalent) therapy is permitted.
• The patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
• The patient is pregnant or breast feeding.
• The patient has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.
• The patient is oxygen-dependent.
• The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
Drug: SL-801
Lymphoma, Solid Tumors, Brain and Nervous System, Breast - Female, Breast - Male, Colon, Corpus Uteri, Esophagus, Kidney, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Other Digestive Organ, Pancreas, Prostate, Stomach, Urinary Bladder, Small Intestine, Unknown Sites
UT Southwestern
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Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)

PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll approximately 1,800 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Girish Kumar
169563
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02381509
STU 032017-040
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Inclusion Criteria:

• Male or Female, age 18 years or older;
• Requires IVC filter for prevention of pulmonary embolism (PE);
• Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
• Willing to comply with the specified follow-up
Exclusion Criteria:

• Subject is unable to participate in study evaluations pre- and post-treatment
• Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms
Device: IVC Filter
Pulmonary Embolism
inferior vena cava filters
UT Southwestern; Children’s Health
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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.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Kevin Courtney
131906
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03170960
STU-2018-0219
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Inclusion Criteria:
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.
Drug: cabozantinib, Drug: atezolizumab, Drug: cabozantinib, Drug: cabozantinib
Endometrial Cancer, Non-Small Cell Lung Cancer, Gastric Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Head and Neck Cancer, Ovarian Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer, Urothelial Carcinoma, Gastroesophageal Junction Adenocarcinoma, Castration-Resistant Prostate Cancer, Differentiated Thyroid Cancer, Anus, Breast - Female, Cervix, Colon, Corpus Uteri, Esophagus, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Other Digestive Organ, Other Female Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Stomach, Thyroid, Urinary Bladder, Small Intestine
Kidney, Bladder, Renal pelvis, Ureter, Urethra, Cancer, Prostate, Castration-resistant, Lung, Breast, Ovarian, Endometrial, Liver, Stomach
UT Southwestern
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A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care (ISABELA2)

The main purpose of this study is to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).
Call 214-648-5005
studyfinder@utsouthwestern.edu
John Fitzgerald
12247
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03733444
STU-2018-0379
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Inclusion Criteria:

• Male or female subject aged ≥40 years on the day of signing the Informed Consent Form (ICF).
• A diagnosis of IPF within 5 years prior to the screening visit, as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis.
• Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy (LB) available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT.
• Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months.
• The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined).
• Meeting all of the following criteria during the screening period: FVC ≥45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity of the lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal.
• Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator.
• Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
• Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening Visit 1; without having a contraindication to perform the 6MWT or without a condition putting the subject at risk of falling during the test (investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all for any condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2) should be ≥88% with maximum 6 L O2/minute; during the walk, SpO2 should be ≥83% with 6 L O2/minute or ≥88% with 0, 2 or 4 L O2/minute.
Exclusion Criteria:

• History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ).
• Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload.
• Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
• Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
• Diagnosis of severe pulmonary hypertension (investigator determined).
• Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).
• Had gastric perforation within 3 months prior to screening or during screening, and/or underwent major surgery within 3 months prior to screening, during screening or have major surgery planned during the study period.
• Moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or total bilirubin ≥1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) ≥3 x ULN. Retesting is allowed once for abnormal LFT.
• Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
• Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.
Drug: GLPG1690, Drug: Placebo
Idiopathic Pulmonary Fibrosis
UT Southwestern
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Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Jaffer Odeh
136385
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04164173
STU-2019-1242
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Inclusion Criteria:
1. Age 18 years and older 2. Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement 3. Cardiac surgery performed via median sternotomy
Exclusion Criteria:
1. BMI>40 2. Refusal to be consented 3. Prior or current lung transplant patients
Device: EzPAP, Device: Metaneb, Device: Intermittent Positive Pressure Breathing (IPPB)
Pulmonary Disease, Postoperative Complications, Cardiovascular
UT Southwestern
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Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04068896
STU-2019-1567
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Inclusion Criteria:
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. -
Biological: NGM120, Biological: NGM120, Biological: NGM120, Biological: NGM120, Biological: NGM120, Biological: NGM120, Other: Placebo
Esophageal Cancer, Non-Small Cell Lung Cancer, Melanoma, Pancreatic Cancer, Gastric Cancer, Bladder Cancer, Colorectal Cancer, Ovarian Cancer, Eye and Orbit, Colon, Esophagus, Larynx, Lip, Oral Cavity and Pharynx, Lung/Thoracic, Melanoma, skin, Ovary, Pancreas, Prostate, Rectum, Stomach, Thyroid, Urinary Bladder, Metastatic Castration-resistant Prostate Cancer, Head Neck Squamous Cell Carcinoma
UT Southwestern
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Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sawsan Rashdan
171142
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT04268550
STU-2020-0287
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Inclusion Criteria:

• Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here:
• Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel
• For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. nivolumab, pembrolizumab, or durvalumab) is allowed
• Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression
• Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration
• Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD)
• Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration
• Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
• Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration
• Patients must be able to swallow capsules
• Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy
• Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration
• Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration)
• Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration)
• Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN
• Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study registration) (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, bilirubin and either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
• Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula (within 28 days prior to sub-study registration)
• Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
• Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
• Patients must have electrolytes and blood urea nitrogen (BUN) performed within 14 days prior to sub-study registration
• Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
• Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
• 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
• 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
• Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
Exclusion Criteria:

• Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted)
• Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
• Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to sub-study registration
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
• Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients must not have a QT interval by Fridericia (QTcF) > 470 msec based on the electrocardiogram (ECG) within 28 days prior to registration. It is suggested that a local cardiologist review the QTcF intervals
• Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled infection, requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus
• Uncontrolled diabetes: Patients who have a diagnosis of diabetes must have an hemoglobin (Hb) A1C < 7% within 28 days prior to registration. The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
• Uncontrolled blood pressure and hypertension: All blood pressure measurements within the 28 days prior to registration must be systolic blood pressure (SBP) =< 180 and diastolic blood pressure (DBP) =< 100. An exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a blood pressure within the parameters above
• Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LOXO-292 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease)
• Patients must not be planning to receive any strong inhibitors or inducers of CYP3A4 at least 14 days prior to sub-study registration and throughout protocol treatment
• Patients must not be planning to use proton pump inhibitors (PPIs) at least one week prior to sub-study registration and throughout protocol treatment
• Patients must not be pregnant or nursing. Women study patients of reproductive potential and fertile men study patients and their partners must abstain or use effective contraception (including barrier method) while receiving study treatment and for at least 3 months after the last dose of LOXO-292. Male study patients must agree not to donate sperm for 6 months after the last dose of LOXO-292. 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
Drug: Selpercatinib
Stage IVA Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma, Lung/Thoracic
UT Southwestern; Children’s Health
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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.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Robert Timmerman
69821
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02645487
STU 022015-106
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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
UT Southwestern; Children’s Health
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Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.

This study is being done to evaluate the safety of the investigational study drug, BGB324 when administered in combination with docetaxel, and to establish the maximum tolerated dose.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT02922777
STU 052015-077
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Inclusion Criteria:
A patient is eligible for the study if the following criteria are met: 1. Provision of written informed consent to participate in this investigational study 2. Histologically or cytologically confirmed advanced (stage 4, according to the American Joint Committee on Cancer [AJCC] Staging manual) NSCLC 3. Up to three previous lines of therapy, of which one must have been a platinum-based doublet therapy and no more than two were cytotoxic chemotherapy. 4. Radiographic disease recurrence or progression during or after the last line of chemotherapy 5. Patients with known activating EGFR mutations or ALK rearrangements should have progressed after appropriate targeted treatment in addition to progressing during or after platinum-based doublet chemotherapy 6. European Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Age 18 years or older 8. Measurable or evaluable disease according to RECIST v1.1 9. Previously treated brain metastases (surgery and/or radiation therapy) are eligible, provided that patients are asymptomatic and not requiring corticosteroids 10. The following minimum intervals are required between prior treatment and initiation of study therapy: Cytotoxic chemotherapy: 3 weeks Molecularly targeted therapy or immunotherapy: 2 weeks Conventional fractionated radiation therapy: 2 weeks Stereotactic radiation therapy: 1 week Major surgery: 3 weeks 11. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500 cells/µL; hemoglobin ≥ 9 g/dL; platelets ≥ 100,000/µL 12. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation) 13. Adequate hepatic function: total bilirubin ≤ upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN). ALT and AST ≤ 5x ULN if documented liver metastases 14. Previous treatment-associated toxicities resolved to CTCAE grade ≤2 (except alopecia) 15. Adequate archival tissue (10-15 slides, or 5 slides with 3 sections per slide) for biomarker analysis 16. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to taking their first dose of BGB324. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for ≥3 months after the last dose of BGB324. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility, including tubal ligation, or evidence of post-menopausal status defined as any of the following:
• Natural menopause with last menses >1 year ago
• Radiation induced oophorectomy with last menses >1 year ago
• Chemotherapy induced menopause with last menses >1 year ago Exclusion Criteria A patient is excluded from the study if any of the following criteria are met: 1. Pregnant or lactating 2. Abnormal left ventricular ejection fraction on echocardiography (less than the lower limit of normal for a patient of that age at the treating institution or <45%) 3. History of an ischemic cardiac event including myocardial infarction within 3 months of study entry 4. NSCLC with evidence of a centrally cavitating lesion 5. Peripheral neuropathy NCI CTCAE ≥Grade 2 at baseline 6. Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within 6 weeks (or within 2 weeks if source definitively treated [eg, radiation therapy or bronchoscopic procedure]) 7. Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity 8. Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within the last three months 9. History or presence of sustained bradycardia (less than or equal to 60 BPM) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias , as defined by the need for treatment 10. Previous treatment with docetaxel or an Axl inhibitor 11. Current treatment with agents that may prolong QT interval and may cause Torsade de Points which cannot be discontinued at least five half-lives prior to treatment. Please see Appendix J for list of relevant medications 12. Known family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy 13. Previous history of Grade 3 or worse drug-induced QTc prolongation requiring treatment withdrawal 14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia's correction >450 ms 15. Ongoing infection requiring systemic treatment 16. Inability to tolerate oral medication 17. Impaired coagulation as evidenced by:
• INR >1.5 times ULN, or
• aPTT > 1.5 times ULN 18. Clinically active existing gastrointestinal disease affecting drug absorption, such as celiac disease or Crohn's disease 19. Previous bowel resection anticipated to affect drug absorption 20. Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol 21. Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index 22. Active, uncontrolled central nervous system (CNS) disease 23. Known active infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (screening not required) 24. Major surgery within 28 days prior to the start of BGB324, excluding skin biopsies and procedures for insertion of central venous access devices
Drug: BGB324, Drug: Docetaxel
Non-Small Cell Lung Carcinoma, Lung/Thoracic
UT Southwestern
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Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy (MUPPITS-1)

Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can sometimes make asthma symptoms worse. This study will help investigators learn about the way colds are related to asthma attacks among children who need higher amounts of medications to control their asthma. Investigators want to learn why viral colds sometimes cause asthma attacks and other times do not by studying the immune system response in samples taken from the nose and blood.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Rebecca Gruchalla
12819
All
6 Years to 17 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02502890
STU 062015-051
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Inclusion Criteria:
Participant(s) who meet all of the following criteria are eligible for enrollment. Participant(s) may be reassessed if not initially eligible. Participants are eligible if they:
• Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Inner City Asthma Consortium (ICAC) Manual of Procedures (MOP);
• Have a diagnosis of asthma made by a clinician >1 year prior to recruitment;
• Have had at least 2 asthma exacerbations in the prior year, defined as a requirement for systemic corticosteroids and/or hospitalization;
• Have the following requirement for asthma controller medication at the Screening and Enrollment Visit (Visit 0) according to the MEDS program[4, 2]:
• For participants aged 6 to 11 years, treatment with at least fluticasone 250 mcg 1 puff twice daily or its equivalent;
• For participants ages12 years and older, treatment with at least Advair 250/50 mcg 1 puff twice daily or its equivalent.
• Have peripheral blood eosinophils >=150 per mm^3. Results can be obtained from participation in a previous ICAC study if obtained within 6 months of the Screening and Enrollment Visit (Visit 0);
• Currently a non-smoker;
• Parent/legal guardian is willing to sign the written informed consent;
• Participant is willing to sign the assent form as per central Institutional Review Board (IRB) guidelines;
• Has some form of insurance that covers costs of usual care asthma control and rescue medications at the Screening and Enrollment Visit (Visit 0).
Exclusion Criteria:
Participant(s) who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participant(s) are ineligible if they:
• Are currently pregnant or lactating;
• Are currently receiving treatment with anti-immunoglobulin E (anti-IgE) therapy or have had anti-IgE therapy in the previous 3 months prior to screening;
• Are currently receiving immunotherapy;
• Have clinically significant abnormalities on complete blood count (CBC) with differential as determined by the site study clinician. Results can be obtained from participation in a previous ICAC study [including Registry for Asthma Characterization and Recruitment 2 (RACR2), NCT02513264} if obtained within the last 6 months of Visit 0;
• Was treated with systemic corticosteroids for any medical condition including an asthma exacerbation within the 2 weeks prior to Visit 0;
• Have had a cold in the previous 7 days;
• Are currently participating in an asthma-related pharmaceutical study or intervention study or has participated in another asthma-related pharmaceutical study or intervention study in the previous 4 weeks prior to recruitment;
• Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) 1 puff twice daily or its equivalent and\or individuals using oral corticosteroids daily or every other day at Visit 0. Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
• Have any medical illnesses that in the opinion of the investigators would a.) increase the risk the participant would incur by participating in the study, b.) interfere with the measured outcomes of the study, or c.) interfere with the performance of the study procedures. Examples of such diseases are: phenylketonuria, cystic fibrosis, bronchiectasis, Type 1 diabetes, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infections, Wiskott-Aldrich syndrome, or allergic bronchopulmonary aspergillosis.
• Have concurrent medical problems that would require systemic corticosteroids (other than for treatment of an asthma exacerbation) or other immunomodulators during the study;
• Currently have diagnosed cancer, are currently being investigated for possible cancer, or have a history of cancer;
• Have plans to move from the area during the study period;
• Do not primarily speak English (or Spanish at clinical sites with Spanish speaking staff);
• Have a primary caretaker who does not speak English (or Spanish at clinical sites with Spanish-speaking staff; not applicable if participant is able to provide consent);
• Are a foster child;
• Will not allow the study clinician to manage their disease for the duration of the study or are not willing to change their asthma medications to follow the protocol;
• Are not able to perform pulmonary function tests;
• Have known hypersensitivity to any of the medications that will be used for the treatment of asthma;
• Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
Asthma, Lung/Thoracic
asthma, nested case-control study, difficult-to-control asthma, asthma exacerbations, cold symptoms, gene expression
UT Southwestern; Parkland Health & Hospital System
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Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02194738
STU 092014-004
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Inclusion Criteria:

• PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
• For pre-surgical patients
• Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible
• Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized
• For post-surgical patients
• Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy
• Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration
• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4
• No patients known to be pregnant or lactating
• Patients who have had local genotyping are eligible, regardless of the local result
• No patients with recurrence of lung cancer after prior resection
• Note: Post-surgical patients should proceed to registration immediately following preregistration
• PATIENT REGISTRATION ELIGIBILITY CRITERIA:
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
• Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology
• Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized
• Patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows:
• Squamous patients:
• No adjuvant therapy permitted, register patient within 77 days following surgery
• Non-squamous patients:
• If no adjuvant therapy, register patient within 75 days following surgery
• If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery
• If adjuvant chemotherapy and radiation, register patient within 285 days following surgery
Drug: Carboplatin, Drug: Cisplatin, Other: Clinical Observation, Drug: Crizotinib, Other: Cytology Specimen Collection Procedure, Drug: Erlotinib, Drug: Gemcitabine Hydrochloride, Biological: Nivolumab, Drug: Paclitaxel, Biological: Pembrolizumab, Drug: Pemetrexed, Drug: Pemetrexed Disodium, Other: Placebo Administration
Lung Adenocarcinoma, Lung Large Cell Carcinoma, Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7, Stage IIB Lung Non-Small Cell Carcinoma AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IB Lung Squamous Cell Carcinoma AJCC v7, Stage II Lung Squamous Cell Carcinoma AJCC v7, Stage IIA Lung Squamous Cell Carcinoma AJCC v7, Stage IIB Lung Squamous Cell Carcinoma AJCC v7, Stage IIIA Lung Squamous Cell Carcinoma AJCC v7, Resectable Lung Non-Small Cell Carcinoma
UT Southwestern; Children’s Health
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Phase I Trial of IV Fenretinide (4-HPR) Plus IV Safingol for Patients With Relapsed Malignancies

In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor. This phase I study represents the first clinical trial employing this promising combination. The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2 of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol increased fenretinide efficacy both during and after safingol administration. The total dose of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been employed to reduce the potential for overlapping hepatic toxicities between these two agents. The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to 1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2 total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in monotherapy portion of this study), and was selected to provide an adequate safety margin against the potential for overlapping toxicities (such as hepatic transaminitis). The study has been designed to optimize the safety of this novel combination. Treatment will be administered in the inpatient setting. Central venous access will be mandated to avoid the potential for hemolysis and thrombophlebitis associated with the preclinical peripheral administration of a previous safingol formulation in rats. To reduce the incidence of hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will also be encouraged to maintain a low-fat diet during fenretinide administration. Serum triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was noted in canine studies at the highest dose of safingol plus fenretinide tested, serum troponin T levels will be monitored daily. To limit the potential for hepatotoxicity resulting from a possible drug interaction observed between intravenous fenretinide, ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT01553071
STU 042011-132
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Inclusion Criteria:
Inclusion Criteria
•Solid Tumor 1. Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. 2. All patients must have measurable disease documented by CT, MRI, or non-measurable disease documented by Physical Exam within 28 days prior to registration. 3. Age >18 years. 4. ECOG performance status of 0
•2 (Karnofsky > 60%). 5. Life expectancy of greater than 3 months. 6. Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count ≥ 1,500/μL
• platelets ≥ 100,000/μL
• total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
• AST (SGOT) ≤ 2.5 x institutional upper limit of normal (IULN) ≤ 5 x IULN for patients with liver metastases
• ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) ≤ 5 x IULN for patients with liver metastases − creatinine within institutional normal limits (WNL) OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal 7. Effects of fenretinide and safingol on the developing human fetus are unknown. For this reason, women of child-bearing potential and men 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. For women of child-bearing potential, a negative serum pregnancy test is required within 72 hours prior to receiving study drug each cycle. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 8. Ability to understand and the willingness to sign a written informed consent document. 9. Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide. Inclusion Criteria
•Non-Hodgkin's Lymphoma 1. Patients must have histologically or cytologically confirmed non-Hodgkin's lymphoma for which standard therapies do not exist or are no longer effective. To be eligible for this study, lymphoma patients must have no marrow involvement as documented by routine marrow aspiration and biopsy performed within 30 days of study entry. 2. All patients must have measurable disease documented by CT, MRI, or non-measurable disease documented by Physical Exam within 28 days prior to registration. 3. Age 18 years or greater. 4. Patients must have adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1500, platelets ≥ 100,000, unless due to direct bone marrow involvement of disease.
• Hemoglobin ≥ 8.0 gm/dL; transfusion permitted to achieve this level
• Serum creatinine ≤ 1.5 x the upper limits of institutional normal (IULN)
• Total bilirubin ≤ 1.5 x the IULN
• AST/ALT ≤ 2.5 x the IULN
• Or ≤ 5 x IULN for patients with liver metastases 5. ECOG performance status of 0
•2 and estimated survival of at least 3 months. 6. Patients must be able to understand and agree to sign an IRB-approved informed consent form. 7. The effects of fenretinide and safingol on the developing human fetus are unknown. For this reason,women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study, and for two months after study participation. For women of child-bearing potential, a negative serum pregnancy test is required within 72hours prior to receiving study drug each cycle. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 8. Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide.
Exclusion Criteria:
1. Radiation therapy, chemotherapy, and other investigational agents within 3weeks (6 weeks for nitrosourea or mitomycin C) prior to starting fenretinide + safingol. Patients must have recovered from toxicities of prior therapy. 2. Concurrent administration of any other investigational agents 3. Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, coagulation disorders; other major medical illnesses of the cardiovascular or respiratory systems or psychiatric illness/social situations that would limit compliance with study requirements. 4. Pregnant women are excluded from this study because the effects of fenretinide and safingol on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fenretinide and safingol, breastfeeding must be discontinued. 5. Major surgery in the last three weeks due to unknown effects of fenretinide and safingol on wound healing. 6. Patients with previously untreated brain metastases (including parenchymal, meningeal or dural-based CNS lesions) are excluded. However, patients with previously treated (surgery, radiation or both), clinically inactive brain metastases, who have not received corticosteroid therapy within three weeks of starting protocol therapy, are eligible. 7. Known allergy to egg products or soy bean oil. 8. Patients known to be HIV-positive receiving anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions. 9. Baseline fasting triglycerides > 2.5 institutional upper limit of normal (IULN) or hypertriglyceridemia requiring medication. Patients requiring medication for other dyslipidemias (i.e., elevated LDL cholesterol) are eligible. 10. Concomitant use of the following drugs (see Concomitant Medications, Section 3.3): antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone. If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives. 11. Poorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%. 12. Patients with an identified familial hyperlipidemia disorder. 13. Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide, such as 13-cis-retinoic acid, retinol, or all-trans-retinoic acid. 14. Patients with esophageal cancer with unresected or recurrent primary tumors in the esophagus are only permitted after discussion of patient with Study Chair due to concern of tumor necrosis and esophageal perforation. 15. Baseline (pre-treatment) serum troponin T (TnT) ≥ 0.03 ng/mL. Troponin T levels may be rechecked and therapy given if levels decrease to < 0.03 ng/mL. 16. Baseline (pre-treatment) EKG with any of the following changes consistent with cardiac ischemia:
• significant ST depression (ST depression of ≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec from the end of the QRS complex)
• significant ST elevation (> 1mm in limb lead or 2 mm in precordial lead measured at a point 0.04 sec (1 mm) after the J-point [the end of the QRS complex] and compared to baseline [line drawn from P start to T end])
Drug: Fenretinide (4-HPR) plus Intravenous Safingol
Solid Tumor, Lung/Thoracic, Hodgkins Lymphoma, Unknown Sites
Malignancy, Relapsed, Chemotherapy, Intravenous
UT Southwestern
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Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer (REACH PC)

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Stephanie Terauchi
166200
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03375489
STU 052018-048
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Inclusion Criteria:

• Patient Eligibility Criteria
• Diagnosed with advanced non-small cell lung cancer being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 3 (symptomatic and in bed >50% of the day)
• The ability to read and respond to questions in English or Spanish
• Receiving primary cancer care at one of the participating sites
• Age > or = 18 years
• Lives in a state where their institutions' palliative care clinicians are licensed to practice
• Caregiver Eligibility Criteria
• Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week.
• The ability to read and respond to questions in English or Spanish
• Age > or = 18 years
Exclusion Criteria:

• Patient Exclusion Criteria
• Already receiving outpatient PC or hospice services
• Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
• Caregiver Exclusion Criteria --Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
Other: Telehealth, Other: In-person PC
Lung Cancer, Lung/Thoracic
Lung Cancer palliative care
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Cockroach Immunotherapy in Children and Adolescents (CRITICAL)

Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma. The primary objective of the study is to determine if asthma severity can be improved by cockroach subcutaneous immunotherapy (SCIT) treatment.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Rebecca Gruchalla
12819
All
6 Years to 16 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03541187
STU 052018-049
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Inclusion Criteria:
Participant(s)
• And/or parent guardian must be able to understand and provide informed consent;
• Age at date of recruitment (e.g., screening):
• in Part A: 8 to 14 years of age
• in Part B: 6 to 16 years of age
• Must have a primary place of residence in one of the pre-selected recruitment census tracts (Reference: Inner-City Asthma Consortium);
• Has a history of persistent asthma, for a minimum of 1 year before study entry:
• Diagnosis of asthma will be defined as a report by the caretaker that the participant had a clinical diagnosis of asthma made by a clinician ≥1 year ago, resulting in a prescription of preventative asthma medication, and
• Must have persistent asthma as defined by the current need for at least 88 mcg fluticasone (or the equivalent of another inhaled corticosteroid) to control asthma at the time of screening.
• At the time of randomization, the participant's asthma must be well controlled as defined by:
• A Forced Expiratory Volume in 1 second (FEV1) ≥80% predicted, and
• An Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) score ≥20.
• Is sensitive to German cockroach as documented by:
• a positive (≥3 mm greater than negative control) skin prick test result, and
• detectable German cockroach specific Immunoglobulin E (IgE) (≥ 0.35 kUA/L).
• Has no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo;
• In Part A only: participant must have a positive cockroach nasal challenge, as defined by reaching a Total Nasal Symptom Score (TNSS) of ≥6 or a sneezing score of 3 at dose 2 or above during the challenge at screening; and
• Have documentation of current medical insurance with prescription coverage at randomization.
Exclusion Criteria:
Participant(s)
• Unable or unwilling to give written informed consent or comply with the study protocol;
• That is pregnant or lactating;
• That are post-menarcheal females must be abstinent or use a medically acceptable birth control method throughout their participation in the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
• That cannot perform spirometry and peak flow at treatment randomization;
• That have an asthma severity classification at the time of treatment randomization of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
• Requires a dose >500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid,
• Has received more than 2 courses of oral or parenteral corticosteroids in the last 12 months or one course within the last 3 months prior to study entry,
• Has been treated with depot steroids within the 3 months prior to study entry,
• Has been hospitalized for asthma within the 6 months prior to study entry, or
• Has had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to study entry.
• Does not have access to a phone (needed for scheduling appointments);
• Has received allergen immunotherapy (Sublingual Immunotherapy [SLIT] or Subcutaneous Immunotherapy [SCIT]) in the last 12 months or, who plan to initiate or resume allergen immunotherapy during the study;
• Has received biologic therapy (e.g., anti-Immunoglobulin E [IgE], anti-IL-4, anti-IL-5) within 6 months of study entry;
• Has received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
• Has past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may:
• pose additional risks from participation in the study,
• may interfere with the participant's ability to comply with study requirements, or
• that may impact the quality or interpretation of the data obtained from the study.
• Who have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy,
• Who meet any of the following criteria are not eligible for enrollment and may not be reassessed:
• That plan to move from the area during the study period,
• Have a history of anaphylaxis grade 3 or higher as defined by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System,
• Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that, in the opinion of the investigator, might interfere with the evaluation of the investigational product or pose additional risk to the participant,
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator,
• may pose additional risks from participation in the study,
• may interfere with the participant's ability to comply with study requirements,
• or that may impact the quality or interpretation of the data obtained from the study.
• Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical).
Biological: German cockroach allergenic extract, Biological: Placebo for German cockroach allergenic extract
Persistent Asthma
cockroach, immunotherapy, inner city asthma, subcutaneous immunotherapy (SCIT), Nasal Allergen Challenge (NAC)
UT Southwestern; Parkland Health & Hospital System
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A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation (RESCUE3)

This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts. The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
Call 214-648-5005
studyfinder@utsouthwestern.edu
David McDonagh
155855
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03783884
STU-2019-0493
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Inclusion Criteria:
1. Are 18 years or older, and, 2. Have been mechanically ventilated for ≥96 hours (4 days), and, 3. Have satisfied the Readiness-to-Wean criteria, and, 4. Have failed at least 2 weaning attempts (of which one was the protocol-specific Ventilator Liberation Trial).
Exclusion Criteria:
1. maximal Inspiratory Pressure (MIP) (absolute value) >50 cm H2O; 2. invasive mechanical ventilation >45 days; 3. currently on ECMO; 4. weaning failure due to hypervolemia; 5. medical history (including imaging) or known anatomy that prevents insertion of LIVE Catheter into the Left Subclavian vein; 6. clinically overt congestive heart failure that is preventing weaning; 7. currently being treated with neuromuscular blockade; 8. pre-existing neuromuscular or muscular dissorder that could affect the respiratory muscles; 9. pre-existing severe chronic pulmonary fibrosis; 10. pleural effusions occupying greater than one third of the pleural space on either side; 11. body mass index (BMI) ≥ 40; 12. known or suspected phrenic nerve paralysis; 13. any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators; 14. current hemodynamic instability, sepsis or septic shock; 15. prior bacteremia within the last 48 hours; 16. terminally ill with 6 months or less of life expectancy or not committed to full care; 17. known or suspected to be pregnant or lactating; 18. treatment with an investigational device or drug within 30 days of enrollment.
Device: Diaphragm Pacing Therapy
Ventilator Induced Diaphragm Dysfunction
VIDD, Diaphragm Atrophy, Weaning Failure, VLT, SBT, VILI, Phrenic nerve stimulation, Maximal Inspiratory Pressure
UT Southwestern
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A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04058353
STU-2019-1108
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Key
Inclusion Criteria:

• Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a gating or residual function mutation (F/G and F/RF genotypes)
• Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height Key
Exclusion Criteria:

• Clinically significant cirrhosis with or without portal hypertension
• Lung infection with organisms associated with a more rapid decline in pulmonary status
• Solid organ or hematological transplantation Other protocol defined Inclusion/Exclusion criteria may apply
Drug: ELX/TEZ/IVA, Drug: IVA, Drug: TEZ/IVA
Cystic Fibrosis
UT Southwestern
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Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

This is a Phase 3, multicenter, open-label and roll-over study in subjects who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Preeti Sharma
117060
All
12 Months and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04235140
STU-2019-1580
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Key
Inclusion Criteria:

• Subjects From Study VX16-809-122 Part B (Study 122)
• Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B
• Subjects Not From Study 122
• Subjects will be 1 to less than 2 years of age
• Homozygous for the F508del mutation (F/F) Key
Exclusion Criteria:

• Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject
• Solid organ or hematological transplantation Other protocol defined Inclusion/Exclusion criteria may apply.
Drug: LUM/IVA
Cystic Fibrosis
Parkland Health & Hospital System
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Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, ALCHEMIST Chemo-IO Study

This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, 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. The purpose of this trial is to find out if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for non-small cell lung cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04267848
STU-2020-0684
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Inclusion Criteria:

• Previously registered to A151216
• Central and/or local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
• Central and/or local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
• Central and/or local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
• Note: Local testing results of EGFR and ALK by a local Clinical Laboratory Improvement Act (CLIA) certified laboratory is acceptable. The report must indicate the result as well as the CLIA number of the laboratory that performed the assay. Local result of PD-L1 by DAKO 22C3, Dako 28-8, EIL3N or SP263 are acceptable for enrollment on A081801. Patients with local results for EGFR, ALK and PD-L1 still need to be registered to A151216 and follow all the submissions requirements but do NOT need to wait for the results to proceed to A081801 registration
• Completely resected stage IB (>= 4 cm), II or IIIA non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 7th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2010
• Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
• Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
• Human immunodeficiency virus (HIV)-infected patients with a history of Kaposi sarcoma and/or multicentric Castleman disease on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 8 gm/dl
• Calculated (Calc.) creatinine clearance >= 45 mL/min
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Exclusion Criteria:

• No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
• No prior allogeneic tissue/solid organ transplant
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
• No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
• No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
• 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 =< 7 days prior to registration is required
• No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
• No hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
• No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
• No known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
Drug: Carboplatin, Drug: Cisplatin, Drug: Gemcitabine Hydrochloride, Other: Observation, Drug: Paclitaxel, Biological: Pembrolizumab, Drug: Pemetrexed Disodium, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Stage IB Lung Squamous Cell Carcinoma AJCC v7, Stage II Lung Squamous Cell Carcinoma AJCC v7, Stage IIA Lung Squamous Cell Carcinoma AJCC v7, Stage IIB Lung Squamous Cell Carcinoma AJCC v7, Stage IIIA Lung Squamous Cell Carcinoma AJCC v7, Lung Non-Squamous Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Stage IB Lung Cancer AJCC v7, Stage II Lung Cancer AJCC v7, Stage IIA Lung Cancer AJCC v7, Stage IIB Lung Cancer AJCC v7, Stage IIIA Lung Cancer AJCC v7, Lung Non-Small Cell Squamous Carcinoma
UT Southwestern; Children’s Health
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A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1 inhibitor durvalumab as first-line therapy in 50 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Jonathan Dowell
11902
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02879617
STU-2020-0099
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Inclusion Criteria:

• Written informed consent
• Patients must have histologically or cytologically confirmed Stage IIIB or IV (American Joint Committee on Cancer, 7th edition; AJCC 7) non-small cell lung cancer.
• Patients must have measurable disease.
• Patients must have not have received any prior therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) for the treatment of stage IV NSCLC.
• Age ≥ 18 years at time of study entry.
• ECOG performance status of 2.
• Life expectancy of greater than 12 weeks.
• Tissue available (archived or fresh tumor biopsy) for the PD-L1 assay.
• Patients must have normal organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (> 1500 per mm^3)
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100 x 10^9/L (>100,000 per mm^3)
• Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤ 5x ULN Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula
• Female subjects must either be of non-reproductive potential OR must have a negative serum pregnancy test upon study entry.
• The effects of durvalumab on the developing human fetus are unknown. For this reason and because immunomodulatory agents are potentially teratogenic, sexually active women of child-bearing potential and men must agree to use adequate contraception (2 methods of effective contraception from screening) from screening, for the duration of study participation, and for at least 90 days following the last infusion of durvalumab.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion Criteria:

• Involvement in the planning and/or conduct of the study; previous enrollment in the present study.
• Participation in another clinical study with an investigational product for cancer during the last 12 months.
• Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
• Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids in excess of prednisone 10 mg/d or equivalent.
• Sensitizing mutations in EGFR or rearrangements in ALK or ROS1.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab.
• Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
• Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids . Patients may be on systemic corticosteroids provided the dose does not exceed prednisone 10 mg/d or equivalent for 1 week prior to study drug administration.
• Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• History of primary immunodeficiency.
• History of allogeneic organ transplant.
• Uncontrolled intercurrent illness.
• Known history of previous clinical diagnosis of tuberculosis.
• History of leptomeningeal carcinomatosis.
• Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
• Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
• Subjects with uncontrolled seizures.
• Pregnant women; breastfeeding should be discontinued.
• Prior history of radiation pneumonitis.
Drug: durvalumab
Lung/Thoracic, Non-Small Cell Lung Cancer NSCLC
PD-L1 (programmed cell death ligand 1)
UT Southwestern
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Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (SWARM-Pa)

Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04596319
STU-2020-0755
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Key
Inclusion Criteria:

• ≥ 18 years old
• Body mass index (BMI) of ≥ 18 kg/m2
• Documented diagnosis of CF
• Evidence of chronic pulmonary Pseudomonas aeruginosa infection
• Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
• FEV1 ≥ 60% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
• Adequate renal function Key
Exclusion Criteria:

• Recent significant weight loss
• Abnormal vital signs at Screening
• History of prolonged QT syndrome
• Use of supplemental oxygen during the day at rest
• Abnormal liver function tests greater than 3X the upper limit of normal (ULN)
• Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable.
• Recent clinically significant infection requiring systemic antimicrobial therapy
• Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis.
• Currently receiving systemic corticosteroids
• Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM)
• Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergillosis)
• Initiation of a CFTR potentiator/corrector therapy, such as Trikafta®, less than 90 days prior to Screening
• Acquired or primary immunodeficiency syndromes
• Active pulmonary malignancy (primary or metastatic)
• History of lung transplantation
• Recent hemoptysis
• Female pregnant or breastfeeding
• Use of tobacco in any form, or use of e-cigarettes/vaping within 6 months prior to Screening
Biological: AP-PA02, Other: Placebo
Cystic Fibrosis, Lung Infection, Lung/Thoracic, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection Pseudomonal
phage, bacteriophage, cystic fibrosis, Pseudomonas, Pseudomonas aeruginosa
UT Southwestern
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Pediatric Adenotonsillectomy Trial for Snoring (PATS)

The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ron Mitchell
124198
All
3 Years to 12 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02562040
STU 012016-080
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Inclusion Criteria:

• Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria:
• Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring > 3 nights per week or more half of sleep time) and
• Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) <1/hour and apnea-hypopnea index (AHI) ≤3/hour and no oxygen saturation (SpO2) desaturation < 90% in conjunction with obstructive events, confirmed on PSG.
• Tonsillar hypertrophy ≥2 based on a standardized scale of 0-4.
• Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.)
• Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).
Exclusion Criteria:

• Previous tonsillectomy, including partial tonsillectomy
• Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., ≥7 episodes/yr in the past year; ≥5 episodes/year over the past 2 years or ≥3 episodes/yr over the past 3 years.)
• Severe obesity (body mass index (BMI) z-score ≥3).
• Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender.
• Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to:
• Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease.
• Bleeding disorders
• Sickle Cell Disease
• Epilepsy requiring medication
• Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia.
• Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma.
• Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior;
• Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone.
• Diagnosis of autism spectrum disorder.
• Intellectual deficit or assigned to a self-contained classroom for all academic subjects.
• History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score ≤60.
• Children/caregivers planning to move out of the area within the year.
• Children in foster care.
• Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.
Procedure: Early Adenotonsillectomy (eAT), Behavioral: Watchful Waiting with Supportive Care (WWSC)
Sleep-Disordered Breathing
Pediatrics, Primary Snoring, Adenotonsillectomy
UT Southwestern; Parkland Health & Hospital System
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Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Tanya Watt
128737
All
2 Years to 21 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03245151
STU 072017-006
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Inclusion Criteria
• ≥2 years and <18 years of age for enrolment in Phase 1 or ≥2 years and ≤21 years of age for enrolment in Phase 2.
• Recurrent or refractory solid tumors
• Phase 1: All solid tumors (measurable or evaluable disease), including primary central nervous system (CNS) tumors; exclusion of hepatoblastoma and lymphomas. Participants with diffuse intrinsic pontine glioma, optic pathway glioma, or pineal tumors with elevated tumor markers (alpha-fetoprotein [AFP] and beta-human chorionic gonadotropin [ß-hCG][or human chorionic gonadotropin [hCG])do not require histological or cytological confirmation of diagnosis
• Phase 2: Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), Rhabdomyosarcoma, High Grade Glioma (HGG) (all must have measurable disease); exclusion of Diffuse Intrinsic Pontine Glioma
• Histologically or cytologically confirmed diagnosis
• Measurable disease that meets the following criteria (Phase 2): 1. RECIST 1.1 (for all tumor types except HGG): At least 1 lesion of ≥1.0 cm in the longest diameter for a non lymph node or ≥1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computed tomography /magnetic resonance imaging (CT/MRI) 2. Response Assessment in Neuro-Oncology (RANO) for high grade glioma (HGG): At least one lesion must be measurable as defined as a bi dimensionally contrast enhancing lesion with clearly defined margins by CT or MRI scan, with a minimal diameter of 1 cm, and visible on 2 axial slices which are preferably at most 5 mm apart with 0 mm skip Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion
• Karnofsky performance score ≥50 for participants>16 year of age and Lansky play score ≥50 for participants ≤16 years of age. Neurologic deficits in participants with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Participants 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
• Prior Therapy
• Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• Cytotoxic chemotherapy or other chemotherapy known to be myelosuppressive: ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil counts): ≥7 days after the last dose of agent
• Monoclonal antibodies: ≥21 days or 3 half-lives (whichever is shorter) of the antibody must have elapsed after the last dose of a monoclonal antibody (including checkpoint inhibitors). Toxicity related to prior antibody therapy must be recovered to Grade ≤1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid. Participants receiving corticosteroids, who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment, are not eligible
• Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ≥21 days after the completion of interleukins, interferons or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation): Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor leukocytes infusion or boost infusion: ≥84 days after infusion and no evidence of graft versus host disease; Autologous stem cell infusion including boost infusion: ≥42 days
• Cellular Therapy: ≥42 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer cells, dendritic cells, etc)
• Radiotherapy (XRT)/External Beam Irradiation including Protons: ≥14 days after local XRT; ≥150 days after total body irradiation, craniospinal XRT or if radiation to ≥50% of the pelvis; ≥42 days if other substantial bone marrow radiation.
• Radiopharmaceutical therapy: ≥42 days after systemically administered therapy.
• Vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR)-targeted or mammalian target of rapamycin (mTOR)-targeted therapies: Must not have received prior exposure to lenvatinib; May have previously progressed on an mTOR inhibitor; No more than 2 prior VEGF/VEGFR-targeted therapies (For Phase 2 only); Must not have received prior VEGF/VEGFR-targeted therapy in combination with an mTOR inhibitor (For Phase 2 only)
• Adequate bone marrow function for participants with solid tumors without known bone marrow involvement
• Adequate bone marrow function for participants with known bone marrow metastatic disease
• Adequate renal function
• Adequate liver function
• Adequate cardiac function
• Adequate neurologic function
• Adequate blood pressure (BP) control with or without antihypertensive medications
• Adequate coagulation
• Adequate pancreatic function
• Adequate metabolic function
• Adequate glycemic control
• Participants must have a minimum body surface area (BSA) of 0.6 m^2 at study entry. Exclusion Criteria
• Participants who have had or are planning to have the following invasive procedures
• Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment
• Central line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment
• Fine needle aspirate within 7 days prior to enrolment
• Surgical or other wounds must be adequately healed prior to enrolment
• For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
• Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment
• Participants having an active infection requiring systemic therapy.
• Participants with a known history of active hepatitis B (defined as hepatitis B surface antigen reactive or hepatitis B virus- deoxyribonucleic [DNA] detected) or known active hepatitis C virus (HCV, defined as HCV- Ribonucleic acid [RNA] detected). Note: No testing for hepatitis B and hepatitis C is required unless mandated by the local health authority.
• Known to be human immunodeficiency virus (HIV) positive. Note: HIV testing is required at screening only when mandated by the local health authority
• Clinical evidence of nephrotic syndrome prior to enrolment
• Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrolment
• Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days prior to enrollment
• Evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment for Participants with HGG
• Diagnosis of lymphoma
• Radiographic evidence of major blood vessel invasion/infiltration.
• Evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease)
• Participants who are currently receiving enzyme-inducing anticonvulsants
• Participants chronically receiving strong cytochrome P450 3A4 (CYP3A4)/P-glycoprotein (P-gp) inhibitors or inducers within 7 days prior to study enrollment
• Females who are breastfeeding or pregnant. For females of childbearing potential, a negative screening pregnancy test must be obtained within 72 hours before the first dose of study drug
Drug: Lenvatinib, Drug: Everolimus
Sarcoma, Recurrent and 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, Kaposis sarcoma, Small Intestine, Soft Tissue
pediatrics, central nervous system tumors, lenvatinib, E7080, everolimus, Ewing sarcoma/peripheral primitive neuroectodermal tumor, rhabdomyosarcoma, high grade glioma, solid tumors
Parkland Health & Hospital System
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A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children (MUPPITS-2)

The purpose of this study is to see if treatment with a medication called Nucala® (mepolizumab), given along with standard asthma care, makes children less likely to have asthma attacks.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Rebecca Gruchalla
12819
All
6 Years to 17 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03292588
STU 102017-012
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Inclusion Criteria:
Study applicant(s) that fulfill all of the inclusion criteria and none of the exclusion criteria are eligible for the study-
• Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent;
• Must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the study's Manual of Procedures (MOP);
• Has had a diagnosis of asthma made >1 year prior to recruitment; --Those who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
• Has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization);
• At Visit 0 (Screening), has the following requirement for asthma controller medication:
• For those ages 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and,
• For those ≥12 years of age, treatment with at least Advair 250/50 mcg dry powder inhaler (DPI), one puff twice daily or its equivalent.
• Has peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or in another Inner-City Asthma Consortium (ICAC) clinical research study within 6 months;
• Is able to perform spirometry at randomization (Visit for treatment assignment);
• Has documentation of current medical insurance with prescription coverage at randomization; and
• Has had varicella or the varicella vaccination.
Exclusion Criteria:
Individual(s) who meets any of the following criteria are not eligible for enrollment or randomization-
• Is not able or willing to give written informed consent or comply with the study protocol;
• Has concurrent (existing) medical problems that would require systemic corticosteroids or other immunomodulator treatments during the study;
• Is currently receiving immunotherapy;
• Is currently receiving treatment with omalizumab or has had omalizumab treatment within 6 months prior to planned participant randomization to treatment assignment;
• Is currently requiring greater than fluticasone 500 mcg administered twice daily plus a long-acting beta agonist (LABA) one puff twice daily or its equivalent, and/or --Individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0 (Screening).
• Is currently pregnant or lactating, or plans to become pregnant during the time of study participation --Note: Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral subcutaneous, mechanical, or surgical contraception).
• Has a known, pre-existing clinically important lung condition other than asthma;
• Has a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization;
• Has known, pre-existing, unstable liver disease;
• Is a current smoker or has a smoking history of 10 or more pack years;
• Has a known immunodeficiency disease;
• Has other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, including eosinophilic granulomatosis with polyangiitis;
• Has a known, active pre-existing parasitic infestation or is undergoing treatment for a parasitic infestation --Note: Once the individual has been successfully treated, the interested study applicant may be reevaluated for study eligibility.
• Positive for use of investigational drugs within 4 weeks of randomization;
• Has a past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the study clinician,
• May pose additional risks from participation in this study,
• May interfere with the participant's ability to comply with study requirements, or
• May impact the quality or interpretation of the data obtained from the study.
• In the event that the study applicant will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow the protocol;
• Has a known history of allergic reaction to previous biologic therapy for asthma; or
• Has had a life threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure.
Biological: Mepolizumab, Drug: Placebo
Asthma
urban setting, children and adolescents, double-masked, placebo-controlled randomized trial, asthma exacerbations (attacks), mepolizumab adjunctive therapy, asthma exacerbations prevention, difficult-to-control exacerbation-prone asthma
UT Southwestern; Parkland Health & Hospital System
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CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes (CHEC-SC)

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Meghana Sathe
68730
All
4 Months and over
N/A
This study is NOT accepting healthy volunteers
NCT03350828
STU 012018-076
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Inclusion Criteria:

• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
• Enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
• Male or female ≥ 4 months of age on day of study visit
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• Sweat chloride equal to or greater than 60 milliequivalent (mEq)/liter by quantitative pilocarpine iontophoresis test (QPIT)
• Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Current treatment with a prescribed commercially approved CFTR modulator for at least 3 months prior to enrollment
• Able to perform the testing and procedures required for this study, as judged by the investigator
Exclusion Criteria:

• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
• Currently enrolled in an investigational trial (including open-label follow-on studies and Expedited Access Pathway (EAP)) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)
Cystic Fibrosis, Lung/Thoracic
CF, Cystic Fibrosis, Sweat, Sweat chloride, CFTR Modulator
UT Southwestern; Parkland Health & Hospital System
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Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)

This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03095612
STU 032017-003
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Inclusion Criteria:

• Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: 1. Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. 2. Age ≥ 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Histologically or cytologically confirmed advanced (stage 4, according to the American Joint Committee on Cancer [AJCC] version 7.0 Staging manual) NSCLC 5. Molecular identification of a KRAS mutation (codons 12, 13, or 61) 6. Tissue available for analysis at time of enrollment for biomarker analysis (may be obtained via biopsy prior to initiation of treatment, or submission of available archival tissue): 10-15 slides, or 5 slides with 3 sections per slide 7. At least one and up to two previous lines of systemic cytotoxic therapy for advanced NSCLC, of which one must have been a platinum-based doublet therapy. Up to four total previous lines of systemic therapy (including immunotherapy and molecularly targeted therapy) 8. Radiographic or clinical disease recurrence or progression during or after the last line of systemic therapy 9. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500 cells/μL; hemoglobin ≥ 9 g/dL; platelets ≥ 100,000/μL. Use of PRBC transfusion to achieve Hgb ≥9.0 mg/dL is allowed. 10. Adequate renal function (calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation) 11. Adequate hepatic function (total bilirubin ≤ upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 2 × ULN and aspartate aminotransferase [AST] ≤ 2 × ULN). ALT and/or AST may be ≤ 5 × ULN if due to liver metastases. If ALT or AST is > 2 and ≤ 5 × ULN in patients with liver metastases, alkaline phosphatase must be ≤ 2.5 × ULN (unless elevated alkaline phosphatase clearly due to skeletal-rather than hepatic-process; eg, normal GGT, presence of multiple bone metastases, absence of bulky and/or central liver metastases). Patients with Gilbert's syndrome are allowed if total bilirubin ≤ 2 × ULN and direct bilirubin is ≤ ULN. 12. Prothrombin time (PT) and/or international normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN if patient is not on anticoagulant therapy (a therapeutic PT and/or INR and aPTT is acceptable if the patient is on anticoagulants) 13. Female patients of childbearing potential must agree to use 2 methods of contraception (including 1 highly effective and 1 effective method of contraception) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use 2 reliable methods of contraception throughout the study and for 3 months after their last dose of medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility (including hysterectomy and/or bilateral oophorectomy, but not tubal ligation alone) or evidence of post-menopausal status defined as any of the following:
• Natural menopause with last menses >1 year ago and confirmed by FSH blood level
• Radiation-induced oophorectomy with last menses >1 year ago
• Chemotherapy-induced menopause with last menses >1 year ago. Male patients and their partners must use 2 reliable methods of contraception, at least one of them a barrier method (if sexually active with a female of child-bearing potential). 14. Measurable disease according to RECIST v1.1 15. Previously treated (surgery and/or radiation therapy) or untreated brain metastases are eligible, provided that patients are asymptomatic and not requiring escalating doses of corticosteroids 16. Previous treatment-associated clinically significant toxicities resolved to CTCAE grade ≤1 (except alopecia) or to their baseline 17. At least 3 weeks or 5 half-lives, whichever is shorter, since receiving systemic anticancer therapy, including investigational agents, prior to starting study therapy. At least 2 weeks since receiving radiation therapy prior to starting study therapy
Exclusion Criteria:

• Patients meeting any of the following exclusion criteria are not eligible to enroll in this study: 1. Patients who are pregnant or lactating 2. Major surgery (excluding skin biopsies and procedures for insertion of central venous access devices) within 2 weeks of first dose of study drug 3. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety 4. Presence of symptomatic brain metastases or brain metastases requiring the escalating doses of corticosteroids to control neurological symptoms 5. Other concurrent cancer (with the exception of non-melanoma skin cancer and low-risk localized prostate cancer on active surveillance) 6. Unstable cardiovascular function:
• Symptomatic ischemia, or
• Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmics is excluded; 1st degree AV block or asymptomatic LAFB/RBBB are not excluded; asymptomatic rate controlled atrial fibrillation is not excluded), or
• Congestive heart failure (CHF) of NYHA Class ≥3, or
• Myocardial infarction (MI) within 3 months 7. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral 8. Pre-existing grade 3 or 4 neuropathy 9. Active Hepatitis A, B or C infection 10. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study) 11. Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment 12. Prior exposure to docetaxel, selinexor, or another selective inhibitor of nuclear transport (SINE) compound 13. Patients unwilling to comply with study protocol.
Drug: Selinexor
Non-Small Cell Lung Cancer, Lung/Thoracic
UT Southwestern
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Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC

This study evaluates the combination of two well-tolerated therapies, osimertinib and Stereotactic Ablative Radiation (SABR).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sawsan Rashdan
171142
All
18 Years to 99 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03667820
STU 122017-017
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Inclusion Criteria
• Written informed consent
• Age > 18 years
• Advanced EGFR exon 19 or 21 mutant NSCLC, not amenable to curative surgery or radiotherapy. EGFR mutations may be demonstrated by standard, clinically accepted methods, including direct gene sequencing, PCR, and NextGen sequencing.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patients must have a life expectancy ≥ 12 weeks.
• Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
• Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
• Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
• Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
• Male patients should be willing to use barrier contraception.
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• At least one lesion, not previously irradiated, that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
• Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
• Absolute neutrophil count >1.5 x 109/L
• Platelet count >100 x 109/L
• Haemoglobin >9.0 g/dL (transfusion is permitted to achieve Hgb ≥9.0 g/dL)
• Alanine aminotransferase <2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or <5 times ULN in the presence of liver metastases
• Aspartate aminotransferase <2.5 times ULN if no demonstrable liver metastases or <5 times ULN in the presence of liver metastases
• Total bilirubin <1.5 times ULN if no liver metastases or <3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
• Serum Creatinine <1.5 times ULN concurrent with creatinine clearance >50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN. Exclusion Criteria
• Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site).
• Previous treatment with osimertinib or any EGFR TKI.
• Previous treatment with immunotherapy or any check point inhibitors.
• Treatment with an investigational drug within five half-lives of the compound
• Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
• Patients with symptomatic CNS metastases who are neurologically unstable
• Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
• History of hypersensitivity to osimertinib (or drugs with a similar chemical structure or class to osimertinib) or any excipients of these agents
• Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
• Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements In addition, the following is considered a criterion for exclusion from the exploratory genetic research:
• Previous allogeneic bone marrow transplant.
• Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Drug: Osimertinib, Radiation: SABR
Non-small Cell Lung Cancer (NSCLC), Lung/Thoracic
UT Southwestern; Children’s Health
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Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas

This is a prospective one-arm, two-stage phase 2 trial of TVB-2640 in KRAS mutant NSCLC patients. 13 patients will be treated with a minimum of 1 cycle of TVB-2640 therapy over 8 weeks.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03808558
STU 022017-058
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Inclusion: 1. Histologically or cytologically confirmed metastatic or advanced-stage NSCLC and molecular identification of KRAS mutation. KRAS mutant NSCLC must be refractory, relapsed, and/or intolerant of combination platinum-doublet chemotherapy and subsequent immune checkpoint inhibitor therapy · Molecular characterization (tissue- or blood-based [ie, cell-free/circulating tumor DNA]) must have been performed and must have demonstrated a KRAS mutation (exon 12, 13, or 61 mutation detected by sequencing) by a CLIA-certified assay (source documentation required). 2. Subjects' EGFR mutation and ALK gene rearrangement status must be known prior to study entry. Subjects with EGFR mutation or ALK gene rearrangement must have progressed after appropriate FDA-approved targeted therapy options prior to eligibility. 3. Patient has evidence of disease progression on most recent line of therapy. 4. Patient has measurable disease by RECIST v1.1 (Eisenhauer, 2009). 5. Age ≥ 18 years. 6. ECOG performance status of 0 or 1. 7. Predicted life expectancy of >3 months. 8. Adequate organ and marrow function as defined below:
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 75,000/mcL
• total bilirubin <2X institutional upper limit of normal
• AST and ALT ≤5X institutional upper limit of normal
• serum creatinine <1.5X institutional upper limit of normal
• LVEF >50%
• QTcF <470msec 9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 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). 10. No significant ischemic heart disease or myocardial infarction within 6 months of first dose of TVB-2640 and with current adequate cardiac function as in 3.1.8. 11. Ability to understand and the willingness to sign a written informed consent. Exclusion: 1. Patient is unable to swallow oral medications or has impairment of GI function or GI disease that may significantly alter drug absorption such as active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome. 2. Patient has a history of risk factors for torsade de pointes such as uncontrolled heart failure, severe hypokalemia with potassium less than 3mM/L, history of long QT syndrome or require use during study participation of concomitant medications known to prolong QT/QTc interval. 3. Patients who require use of strong CYP3A4/5 agonists or inhibitors during study participation. 4. Patient has uncontrolled or severe intercurrent medical condition including uncontrolled brain metastases. Patients with stable brain metastases either treated or untreated, on a stable dose of steroids/anticonvulsants, with no dose increase within 4 weeks before the first dose of TVB-2640, and no anticipated dose change, are allowed. 5. Patient underwent major surgery within 4 weeks before the first dose of TVB-2640 or received cancer-directed therapy either chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc. or an investigational drug or device within 2 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent, whichever is shorter before the first dose of TVB-2640. In addition, any drug- related toxicity, with the exception of alopecia, an endocrinopathy controlled with replacement therapy, or a clinically stable toxicity not expected to increase from study therapy (eg, cisplatin-associated ototoxicity) should have recovered to
Drug: TVB-2640
KRAS Gene Mutation, Lung/Thoracic
UT Southwestern
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A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Sonja Bartolome
115047
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03496623
STU 052018-035
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Inclusion Criteria:
Participants who meet the following criteria may be included in the study: 1. Participant voluntarily gives informed consent to participate in the study. 2. Males and females 18 years of age and above at the time of informed consent. 1. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, [<1% per year], such as approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug. Participants must have a negative pregnancy test at the Screening Visit 1 (urine [prior to the first dose of study medication] and serum) and Baseline Visit (Study Week 1) (urine). 2. Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug. 3. Diagnosis of PH-COPD (World Heath Organization [WHO] Group 3). 4. Clinical diagnosis of COPD will be made using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria (GOLD Criteria 2020) and spirometry with the following documented parameters measured during Screening Visit 1 (prior to start of low-dose inhaled treprostinil): 1. Forced expiratory volume in 1 second (FEV1) <80% predicted 2. FEV1/Forced vital capacity (FVC) <70 5. The participant has a resting saturation peripheral capillary oxygenation (SpO2) greater than or equal to 90%, with or without supplemental oxygen, but not to exceed 10 liters (L)/min oxygen supplementation by any mode of delivery during Screening Visit 1. 6. During Screening Visit 1 prior to start of low-dose inhaled treprostinil, a 6MWD greater than or equal to 100 meters. 7. Have a right heart catheterization (RHC) performed during Screening Visit 1. (A previous RHC obtained within 12 months prior to the start of Screening Visit 1 is acceptable for determining eligibility, even if done without oxygen or vasodilator challenge, and a repeat RHC is not required.) The following parameters must be documented for eligibility: 1. Pulmonary vascular resistance (PVR) greater than or equal to 4 Wood units 2. A pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) of less than or equal to 15 millimeters of mercury (mmHg) 3. A Pulmonary artery pressure mean (PAPm) of greater than or equal to 30 mmHg 8. Participants must be on a stable and optimized dose of chronic COPD medications for greater than or equal to 30 days prior to start of Screening Visit 1 and remain on the same dose throughout the Screening Period. 9. In the opinion of the Investigator, the participant can communicate effectively with study personnel and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
Exclusion Criteria:
The following will exclude participants from the study: 1. The participant has a diagnosis of either pulmonary arterial hypertension (PAH) or pulmonary hypertension (PH) due to reasons other than COPD. This would include, but is not limited to, chronic thromboembolic PH or acute/recent deep vein thrombosis or pulmonary embolism, untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma or systemic lupus erythematosus), sarcoidosis, human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications. 2. Based on chest computed tomography (CT) imaging during Screening Visit 1, the participant has a confirmed diagnosis of WHO Group 3 PH, other than COPD, such as idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease or interstitial lung disease. A previous chest CT scan performed within the 6 months prior to the start of Screening Visit 1 is also acceptable, and a repeat assessment is not required. A redacted CT scan report (from Screening Visit 1 or dated within prior 6 months) should be provided to the Medical Monitor with the Pre-Baseline Review Form to confirm eligibility. 3. The participant has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (that is, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist [ERA], phosphodiesterase type 5 inhibitor [PDE5-I], or soluble guanylate cyclase [sGC] stimulator) at Screening Visit 1 and thereafter, except if received for acute vasoreactivity testing. 4. The participant has a previous diagnosis of homozygous alpha-1 antitrypsin deficiency. 5. The participant has any prior intolerance to inhaled prostanoid therapy. 6. Inability to tolerate low-dose (3 breaths, 18 mcg) study drug and/or inability to follow dosing regimen during the Screening Period (pre-randomization). 7. Unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device). 8. The participant has evidence of clinically significant left-sided heart disease (including but not limited to left ventricular ejection fraction <40%, left ventricular hypertrophy,) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor Medical Monitor is needed. 9. Any exacerbation of COPD (including hospitalization or outpatient therapy) or active pulmonary or upper respiratory infection 60 days prior to start of Screening Visit 1 through the Baseline Visit. This is defined as worsening of respiratory symptoms that required treatment with corticosteroids and/or antibiotics. 10. Initiation of pulmonary rehabilitation within 12 weeks prior to start of Screening Visit 1 or, in the opinion of the Investigator, pulmonary rehabilitation is likely to be needed during the study Treatment Period. 11. The participant has any form of congenital heart disease (repaired or unrepaired; other than a patent foramen ovale). 12. The participant has any musculoskeletal disorder (severe arthritis of the lower limbs which limits ambulation, recent hip or knee joint replacement, artificial leg) or any other condition that would likely be the primary limitation to ambulation. 13. Use of any other investigational drug or device within 30 days prior to the start of Screening Visit 1. 14. Any other clinically significant illness or abnormal laboratory value(s) measured during the Screening Period that, in the opinion of the Investigator, might adversely affect the interpretation of the study data or safety of the participant.
Drug: Inhaled treprostinil solution, Drug: Placebo solution
Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension, COPD, Inhaled Treprostinil, 6-Minute Walk Test, Tyvaso
UT Southwestern
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Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Puneeth Iyengar
116037
All
18 Years to 130 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03703297
STU-2018-0261
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Inclusion criteria: 1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III). 2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules. 3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP. 4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment. Exclusion criteria: 1. Extensive-stage SCLC 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. 4. Active infection including tuberculosis, HIV, hepatitis B and C 5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
Drug: Durvalumab, Drug: Tremelimumab, Other: Placebo
Small Cell Lung Cancer, Lung/Thoracic
Small Cell Lung Cancer, SCLC, LS-SCLC, Limited Stage, Carcinoma, Lung Cancer
UT Southwestern; Children’s Health
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Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sawsan Rashdan
171142
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03851445
STU-2019-0578
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5.1 Registration Step 0: 1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission. Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step 1. Patients registered at Step 0 must use the same SWOG patient ID for registration at Step 1. Step 1: 2. Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed. 3. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment. These criteria are: 1. Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy.
• For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1 therapy for Stage III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the date or initiation of such therapy.
• For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). 2. Pre-Screening prior to progression on current treatment: To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted. 4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.
• The local interpreting pathologist must review the specimen.
• The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment. Patients must agree to have any tissue that remains after testing retained for the use of sub-study Translational Medicine (TM) studies at the time of consent the patient is enrolled in. 5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted therapy. EGFR/ALK/ROS/BRAF testing is not required prior to Step 1 registration, as it is included in the Foundation One testing for screening/pre-screening. 6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration. 7. Patients must be ≥ 18 years of age. 8. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0. 9. Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form. 10. As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) 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. 11. 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. 12. U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to receive the Amazon gift card (see Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must still participate in the main study.
Drug: Screening Platform
Previously Treated Non-Small Cell Lung Cancer, Lung/Thoracic
UT Southwestern; Children’s Health
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