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62 Study Matches

The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis (GROW)

The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Meghana Sathe
68730
All
2 Years to 11 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03020719
STU 082016-087
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Inclusion Criteria:
1. Male or female ≥ 2 and < 11 years of age at Visit 1 2. Documentation of a CF diagnosis as evidenced by the following criteria: Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) AND Two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene 3. Weight-for-age between the 10th and 50th percentiles at Screening (Visit 1) (using the Center for Disease Control (CDC) reference equations) 4. Current chronic use, greater than 8 weeks before Day 0, of pancreatic enzyme replacement therapy (PERT) for management of pancreatic insufficiency 5. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability to comply with the requirements of the study 6. Clinically stable with no significant changes in health status within 2 weeks prior to Day 0
Exclusion Criteria:

• 1. Intestinal obstruction or gastrointestinal surgery within the 6 months prior to Day 0 2. History of diabetes, Crohn's disease, celiac disease, or bowel resection 3. Use of either oral or inhaled GSH or N-acetyl cysteine within the 4 months prior to Screening (Visit 1) 4. Known hypersensitivity to oral glutathione or lactose 5. Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, Pulmozyme, Cayston TOBI Kalydeco,Orkambi, Proton Pump Inhibitor, Histamine H-2 Blocker [PPI/H2-blocker], Miralax® , PERT, dietary supplementation, probiotics) within the 4 weeks prior to Day 0 6. Changes in the amount of proprietary dietary supplement formulas (e.g., Scandishakes, Boost, Pediasure, or homemade formula) given (oral or gastrostomy tube) within the 4 weeks prior to Day 0 7. Use of antibiotics (oral, IV, or inhaled) for acute symptoms within the 2 weeks prior to Day 0 8. Use of oral steroids within the 4 weeks prior to Day 0 9. Active treatment for nontuberculous mycobacteria (NTM) at Day 0 10. Active treatment for allergic bronchopulmonary aspergillosis (ABPA) at Day 0 11. Administration of any investigational drug within the 30 days prior to Day 0 12. Sibling who received study drug as part of this study 13. 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
Drug: Oral Glutathione, Drug: Placebo
Cystic Fibrosis
Growth Parameters, Cystic Fibrosis
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Standardized Treatment of Pulmonary Exacerbations II (STOP2)

Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed. A strong desire among clinicians to reduce treatment durations (and reduce cost, inconvenience, and potential toxicities) is in conflict with belief that patients not responding robustly to treatment might benefit from extending treatment. This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT02781610
STU 032016-078
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Inclusion Criteria:
Key
Inclusion Criteria:

• Male or female ≥18 years of age at Visit 1
• Documentation of a CF diagnosis
• Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to Visit 1 (US sites only)
• At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary exacerbation
• Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit 3
• Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3
• Willing to adhere to a specific treatment duration determined by initial response to treatment and subsequent randomization
• Willing to return for follow up Visit 3
• Written informed consent obtained from the subject or subject's legal representative
Exclusion Criteria:
Key Exclusion Criteria
• Previous randomization in this study
• Treatment with IV antibiotics in the 6 weeks prior to Visit 1
• Admission to the intensive care unit for current pulmonary exacerbation in the two weeks prior to Visit 2, unless admission was due to a desensitization protocol
• Pneumothorax in the two weeks prior to Visit 2
• Primary diagnosis for current hospitalization is unrelated to worsening lower respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction syndrome (DIOS), sinusitis)
• Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4 consecutive days occurring in the two weeks prior to Visit 2
• Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
• At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with prednisone equivalent to >10mg/day
• History of solid organ transplantation
• Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex) in the two weeks prior to Visit 2
Drug: Standard of care IV antibiotic(s)
Pulmonary Cystic Fibrosis
Cystic fibrosis, Pulmonary exacerbation, Antibiotic, Treatment duration, Lung infection, Cystic Fibrosis Foundation, Cystic Fibrosis Foundation National Patient Registry
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Reducing Disparities in the Quality of Advance Care Planning for Older Adults (EQUALACP)

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studyfinder@utsouthwestern.edu
Ramona Rhodes
111049
All
65 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03516994
STU 052018-047
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Inclusion Criteria for Patients:
• African-American or White
• age 65 or greater
• English-speaking
• residing in non-institutional setting
• cognitively able to participate in advance care planning
• Serious or chronic illness including: metastatic cancer; end stage renal disease; advanced liver disease, heart disease or lung disease; amyotrophic lateral sclerosis, severe Parkinson's disease; 2 or more unplanned hospitalizations in the last year; requiring assistance with any basic activity of daily living
• Serious illness based on the following: Clinician answers "no" to the surprise question: "Would you be surprised if this person died in the next 12 months?" Exclusion Criteria for Patients:
• residence in nursing home or assisted living facility
• diagnosis of dementia or unable to consent
• documented advance care plan (living will, health care proxy, MOST form, provider note)
• current or prior use of hospice
• current or prior use of non-hospice palliative care except inpatient palliative care consultation
Behavioral: Respecting Choices First Steps, Behavioral: Five Wishes Form
Congestive Heart Failure, End Stage Renal Disease, Metastatic Cancer, Diabetes Complications, Parkinson Disease, Interstitial Lung Disease, Amyotrophic Lateral Sclerosis, Chronic Obstructive Pulmonary Disease, End Stage Liver Disease
Advance Care Planning, Disparities, Palliative Care, End of Life Care, African Americans
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Gender Disparity and Hormones in Cystic Fibrosis

The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago. However, females have been shown to have a survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The hypothesis is that estrogen and/or progesterone negatively impact lung health in CF. Therefore, understanding the impact of sex hormones (including the use of birth control pills) on the disease process is increasingly important. The purpose of this study is to determine if lung function, respiratory symptoms, or various markers of lung health change during different phases of the natural ovulatory cycle in order to understand if estrogen or progesterone hormones are impacting the disease relative to fluctuations in men with stable testosterone levels. The research objectives of this project are to: - Determine if lung function, respiratory symptoms, or various markers of lung health change during different hormonal phases of the ovulatory cycle in women. - Determine if men change lung function, respiratory symptoms, or various markers of lung health over time. - Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and improve lung health.
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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02036879
STU 072013-079
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Inclusion Criteria:

• Male and female cystic fibrosis patients
• Must be greater than or equal to 18 years of age.
• All subjects must understand and sign the informed consent.
• Subjects must have the ability to read and write in English.
• Female subjects starting this study must be willing to use a double barrier method of birth control (such as condom or diaphragm) used with a spermicide (a substance that kills sperm), while participating in the study. Exclusion Criteria for Main Study:
• Women who are pregnant, breast feeding, or who have had an oophorectomy.
• Women who have received a hormone contraceptive injection (such as Depo Provera) within the last 3 months. Exclusion Criteria for Substudy:
• Men
• Women who have a history of breast cancer, abnormal vaginal bleeding, liver disease, coronary artery disease, cerebrovascular disease, uncontrolled hypertension, diabetes mellitus with vascular disease, or have had a stroke, heart attack, or blood clot within the past year, due to a possible reaction to Loestrin.
• Women who currently smoke cigarettes, due to the increased risk of serious cardiovascular events with Loestrin use.
Drug: Loestrin (norethindrone acetate and ethinyl estradiol)
Cystic Fibrosis (CF)
Cystic Fibrosis, Loestrin, Hormone
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Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Theodore Laetsch
148176
All
1 Month and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03215511
STU 112017-078
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Key
Inclusion Criteria:

• Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
• A solid tumor diagnosis in the setting of: 1. a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor 2. a documented NTRK fusion unresponsive to a prior TRK inhibitor 3. a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
• NTRK gene fusions will be identified via a CLIA certified (or equivalent) laboratory. Exception: Patients with Infantile Fibrosarcoma (IFS) and congenital mesoblastic nephroma (CMN) may be enrolled based on ETV6+ FISH test without identifying NTRK3
• Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3 (age ≥16) or Lansky Performance Score (LPS) ≥40% (age<16). If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Status (KPS) (age ≥16) or LPS (age<16) ≥ 50%
• Life expectancy > 4 weeks
• Adequate hematologic, hepatic and renal function.
• Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for 7 days prior to the first dose of LOXO-195
• Ability to receive study drug orally or by enteral administration Key
Exclusion Criteria:

• Required treatment with certain strong CYP3A4 inhibitors or inducers.
• Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195 or prolongation of the QT interval corrected (QTcF) > 480 msec within the past 6 months
• Major surgery within 7 days of enrollment
• Uncontrolled systemic bacterial, fungal or viral infection
• Pregnancy or lactation.
• Known hypersensitivity to any of the components of LOXO-195 or Ora-Sweet® SF and OraOlus, for patients receiving liquid suspension
Drug: LOXO-195
Sarcoma, Melanoma, Colorectal Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Congenital Mesoblastic Nephroma, Glioblastoma, Ovarian Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms, Head and Neck Squamous Cell Carcinoma, Central Nervous System Neoplasms, Thyroid Cancer, Thyroid Neoplasms, Skin Carcinoma, Biliary Tract Neoplasms, Astrocytoma, Salivary Gland Neoplasms, Brain Neoplasm, Primary, Bile Duct Neoplasms, Pontine Glioma, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms, Nerve Tissue, Nevi and Melanomas, Intestinal Neoplasms, GIST, Malignant Peripheral Nerve Sheath Tumors, Breast Secretory Carcinoma, Uterine Neoplasms, Fibrosarcoma, Infantile Fibrosarcoma
NTRK Fusion Positive, LOXO-195, Loxo, TRK, TRK Fusion, NTRK1, NTRK2, NTRK3, TRKA, TRKB, TRKC, NTRK, ETV6, fusion, tumors, CNS tumors, solid tumors, central nervous system tumors, advanced cancer, primary CNS tumor, Advanced CNS tumor, Metastatic CNS tumor, NTRK1 fusion, NTRK2 fusion, NTRK3 fusion, ETV6-NTRK3, ETV6 fusion, Metastatic cancer, Cancer of Unknown Primary Site, Pediatric, NTRK1 gene rearrangement, NTRK2 gene rearrangement, NTRK3 gene rearrangement, ETV6 gene rearrangement, NTRK gene rearragements, Congenital Nephroma, Metastatic Infantile Fibrosarcoma, Advanced Infantile Fibrosarcoma
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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
12 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03451045
STU 112017-037
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Inclusion Criteria:
1. ≥ 12 years of age at the time Informed Consent/ Assent is signed. 2. Weight ≥ 40 kg. 3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months. 4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.
Exclusion Criteria:
1. Severe or unstable CF at screening or Visit 1. 2. Any of the following values for laboratory tests at screening: 1. A positive pregnancy test. 2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females. 3. Neutrophils < 1.0 x 10^9 /L. 4. Platelets < 75 x 10^9/L. 5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation. 6. Serum transaminases > 2.5 x upper limit of normal. 3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Drug: Lenabasum 20 mg, Drug: Lenabasum 5 mg, Other: Placebo
Cystic Fibrosis
Pulmonary exacerbation, lenabasum, JBT-101
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A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed iNO in Subjects With Pulmonary Fibrosis

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studyfinder@utsouthwestern.edu
Sonja Bartolome
115047
All
18 Years to 85 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03267108
STU 102017-024
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Inclusion Criteria:
1. Signed Informed Consent 2. Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using guidelines, as per American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT): Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
• Idiopathic pulmonary fibrosis
• Idiopathic nonspecific interstitial pneumonia
• Respiratory bronchiolitis-interstitial lung disease
• Desquamative interstitial pneumonia
• Cryptogenic organizing pneumonia
• Acute interstitial pneumonia
• Rare IIPs diagnosis by one of the following:
• Idiopathic lymphoid interstitial pneumonia
• Idiopathic pleuroparenchymal fibroelastosis
• Unclassifiable idiopathic interstitial pneumonias Chronic hypersensitivity pneumonitis Occupational lung disease 3. At least 50% of the subjects will have confirmed intermediate or high probability of pulmonary hypertension as determined by echocardiography according to the 2015 ESC/ERS Guidelines for Diagnosis and Treatment of Pulmonary Hypertension. 4. Have been using oxygen therapy by nasal cannula for at least 4 weeks prior to the screening run-in period. 5. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization 6. WHO Functional Class II-IV 7. Forced Vital Capacity ≥ 40% predicted within last 6 months prior to screening the screening run-in period. 8. For at least 1 week prior to Baseline/Randomization, subjects must demonstrate the ability to consistently use the device greater than 12 hrs/day in the opinion of the Investigator. 9. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female subjects should take adequate precaution to avoid pregnancy. 10. Subjects must have completed at least 1 week of activity monitoring prior to the Baseline/Randomization visit. 11. Age between 18 and 85 years (inclusive) 12. Subject should be clinically stable for at least 4 weeks prior to Baseline/Randomization in the opinion of the Principal Investigator.
Exclusion Criteria:
1. Demonstrate symptomatic rebound defined as significant cardiopulmonary instability, such as systemic arterial oxygen desaturation, hypoxemia, bradycardia, tachycardia, systemic hypotension, shortness of breath, near-syncope, and syncope, occurring within 1 hour of acute iNO during rebound testing 2. Episodes of disease worsening within 1 month prior to Baseline/Randomization 3. Use of any PAH-specific medications regardless of reason for use 4. Acute or chronic physical impairment (other than dyspnea due to PF) that would limit the ability to comply with study procedures or adherence to therapy (i.e., 6MWT), including carrying and wearing the pulsed delivery device per study protocol, or medical problem(s) likely to preclude completion of the study 5. Pregnant or breastfeeding females at Screening 6. Administered L-arginine within 1 month prior to Screening 7. The concurrent use of the INOpulse device with a continuous positive airway pressure (CPAP), Bilevel positive airway pressure (BPAP), or any other positive pressure device. 8. Use of investigational drugs or devices within 1 month prior to Screening (other than acute vasodilator testing with iNO) 9. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study including unable to complete 6MWT. 10. Any subject who has been enrolled in any previous clinical study with inhaled NO administered through pulse delivery 11. In the last 6 months prior to screening, evidence of any connective tissue disease with FVC > 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the Investigator 12. Evidence of clinically significant Combined Pulmonary Fibrosis and Emphysema (CPFE) if > 15% of lung fields by CT scan show evidence of emphysema in the opinion of the Investigator
Drug: iNO, Drug: Placebo
Pulmonary Hypertension, Pulmonary Fibrosis
Pulmonary Fibrosis, PF, Pulmonary Hypertension, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, Oxygen
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Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)

Call 214-648-5005
studyfinder@utsouthwestern.edu
Trushil Shah
169968
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03399604
STU 012018-063
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Inclusion Criteria:

• signed informed consent by patient prior to study enrollment
• 18 years of age or older
• If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary.
• The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or 2. Heritable PAH (1.2), or 3. Drug and toxin induced PAH (1.3), or 4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
• The patient has been diagnosed with PAH and is NYHA Functional Class II
•IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or 2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.
• The patient can complete a baseline six-minute walk distance (6MWD) ≥ 150 m.
• The patient has had evidence of FEV1 ≥ 60% and FEV1/FVC ratio ≥ 60% during the 6-month period prior to enrollment.
Exclusion Criteria:

• The patient's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.
• Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]).
• The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag.
• The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline.
• The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline.
• The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
• The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).
• The patient has had an atrial septostomy.
• The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.).
• The patient is taking any excluded medications listed in the Investigator's Brochure, namely inhibitors and inducers of CYP2C8
• The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment).
• The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.
• The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening.
• The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening.
• The patient is pregnant or lactating.
• The patient has any musculoskeletal disease or any other disease that would limit ambulation.
• The patient has participated in an investigational product or device study within the 30 days prior to Screening.
• The patient has current evidence of drug abuse in the opinion of the Investigator.
• The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.
• The patient has severe renal impairment (eGFR < 35).
• The patient is taking inhaled treprostinil doses of greater than 90 μg (more than 15 breaths). Additional Exclusion Criteria for PK Sub-Study:
• The patient meets any of Primary Exclusion Criteria #1
•19.
• The patient has moderate or severe renal impairment (eGFR < 60).
• The patient is taking inhaled treprostinil doses of greater than 72 μg (more than 12 breaths).
Drug: LIQ861 Inhaled Treprostinil
Primary Pulmonary Hypertension
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Drug Induced Pulmonary Arterial Hypertension, Toxin Induced Pulmonary Arterial Hypertension, Connective tissue disease
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Milrinone in Congenital Diaphragmatic Hernia

Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Vedanta Dariya
153943
All
up to 168 Hours old
Phase 2
This study is NOT accepting healthy volunteers
NCT02951130
STU 042017-055
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Eligibility criteria: Infants are eligible if they meet all of the following criteria:
• ≥ 36 0/7 weeks PMA by best obstetric estimate AND birth weight of ≥ 2000g
• postnatal age ≤7 days (168 hours of age)
• invasive mechanical ventilation (defined as ventilation with an endotracheal tube) and
• one arterial blood gas with an OI ≥ 10 (after tracheal tube obstruction and other easily resolvable mechanical causes for increased OI are ruled out) on the most recent arterial blood gas within 12 hours prior to the time of randomization.
• if an arterial blood gas is not available at the time of randomization, a preductal OSI of ≥ 5 can be used as an inclusion criterion instead of OI ≥ 10; (the OSI should be based on the most recent preductal pulse oximetry recording and must be within 12 hours of randomization)
• postnatal blood gas with PCO2 ≤ 80 mmHg (arterial, capillary or venous blood gas) on the most recent blood gas sample obtained within 12 hours prior to randomization Note: Criteria (iv) to (vi) must be met at the most recent analysis within 12 hours prior to randomization.
Exclusion Criteria:
Infants are ineligible if they meet any of the following criteria:
• known hypertrophic cardiomyopathy
• Note 1: infants of diabetic mothers with asymmetric septal hypertrophy can be included as long as there is no evidence of obstruction to left ventricular outflow tract on echocardiogram,
• Note 2: infants with other acyanotic congenital heart disease (CHD) and CDH may be included in the study and will be a predetermined subgroup for analysis)
• cyanotic CHD
•transposition of great arteries (TGA), total anomalous pulmonary venous return (TAPVR), partial anomalous pulmonary venous return (PAPVR), truncus arteriosus (TA), tetralogy of Fallot (TOF), single ventricle physiology
•hypoplastic left heart syndrome (HLHS), tricuspid atresia, critical pulmonic stenosis or atresia etc.,
• enrolled in conflicting clinical trials (such as a randomized controlled blinded trial of another pulmonary vasodilator therapy); Note: mothers enrolled in fetal tracheal occlusion studies such as FETO may be enrolled if permitted by investigators of the fetal tracheal occlusion study; [FETO refers to fetoscopic endoluminal tracheal occlusion and involves occlusion of fetal trachea with a balloon device at mid-gestation and subsequent removal in later gestation]
• infants with bilateral CDH o Note 3: infants with anterior and central defects are included in the study
• associated abnormalities of the trachea or esophagus (trachea-esophageal fistula, esophageal atresia, laryngeal web, tracheal agenesis)
• renal dysfunction (with serum creatinine > 2 mg/dL not due to maternal factors) or severe oligohydramnios associated with renal dysfunction at randomization; renal dysfunction may be secondary to renal anomalies or medical conditions such as acute tubular necrosis
• severe systemic hypotension (mean blood pressure < 35 mm Hg for at least 2 h with a vasoactive inotrope score of > 30)
• decision is made to provide comfort/ palliative care and not full treatment
• Intracranial bleed (including the following findings on the cranial ultrasound)
• Cerebral parenchymal hemorrhage
• Blood/echodensity in the ventricle with distension of the ventricle
• Periventricular hemorrhagic infarction
• Posterior fossa hemorrhage
• Cerebellar hemorrhage
• persistent thrombocytopenia (platelet count < 80,000/mm3) despite blood product administration on the most recent blood draw prior to randomization
• coagulopathy (PT INR > 1.7) despite blood product administration on the most recent blood draw (if checked
•there is no reason to check PT for the purpose of this study)
• aneuploidy associated with short life span (such as trisomy 13 or 18) will not be included in the study (infants with trisomy 21 can be included in the study)
• elevated arterial, venous or capillary PCO2 > 80 mmHg in spite of maximal ventilator support (including high frequency ventilation) on the most recent blood gas obtained within 12 hours prior to randomization
• use of milrinone infusion prior to randomization (the use of other inhaled pulmonary vasodilators such as iNO, inhaled epoprosternol, inhaled PGE1 and oral such as endothelin receptor antagonists is permitted
•Note: it is unlikely to be on oral pulmonary vasodilators early in the course of CDH)
• ongoing therapy with parenteral (intravenous or subcutaneous) pulmonary vasodilators such as IV/SQ prostacyclin analogs (Epoprostenol
•Flolan or Treprostinil
•Remodulin or PGE1
•Alprostadil) or IV phosphodiesterase 5 inhibitors (sildenafil
•Revatio) at the time of randomization. In addition, initiation of therapy with these two classes of parenteral medications during the first 24 hours of study drug initiation is not permitted and will be considered a protocol deviation. The risk of systemic hypotension is high during the first 24 hours of study-drug (milrinone) infusion and hence parenteral administration of other pulmonary vasodilators is avoided to minimize risk of hypotension.
• Subjects already on ECMO or patients who are being actively considered for ECMO by the neonatal or surgical team
• attending (neonatal, critical care or surgical) refusal for participation in the trial (including concern about presence of hemodynamic instability)
Drug: Milrinone, Drug: Placebo (5% Dextrose)
Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia
CDH, PPHN, HRF
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Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis (ENCORE-NF)

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.
Call 214-648-5005
studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02686762
STU 042016-062
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Inclusion Criteria:
1. Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study 2. Histological evidence of definite NASH based on NASH CLinical Research Network (CRN) criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1 3. NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2) 4. Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System a. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome 5. Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug 6. If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)
Exclusion Criteria:
1. Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator's judgement 2. Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses 3. Uncontrolled diabetes (HbA1c ≥9%) within 60 days prior to Day 1 4. Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading) 5. Hepatitis and fibrosis more likely related to etiologies other than NASH such as: 1. alcoholic steatohepatitis 2. autoimmune hepatitis 3. hepatitis B virus (HBV) infection 4. hepatitis C virus (HCV) infection 5. primary biliary cirrhosis 6. primary sclerosing cholangitis 7. Wilson's disease 8. alpha-1-antitrypsin deficiency 9. hemochromatosis or iron overload 10. drug-induced liver disease 11. other biliary liver disease 6. ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert's as documented in the medical records) 7. Alpha-fetoprotein >200 ng/mL 8. Hemoglobin <10 g/dL 9. White blood cell count <2.0 x 10^3/mm3 10. Estimated creatinine clearance <30 mL/min 11. Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications 12. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy 13. Inability to safely obtain a liver biopsy 14. Known human immunodeficiency virus (HIV) infection 15. Weight loss ≥ 10% within 6 months of Day 1 16. Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement 17. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured 18. Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening 19. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval >480 milliseconds (msec) 20. Prior or planned (during the time frame of the study) bariatric surgery 21. If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding 22. Previous treatment with emricasan or active investigational medication in a clinical trial within 6 months prior to Day 1 23. Prior liver transplant
Drug: Emricasan (5 mg), Drug: Emricasan (50 mg), Drug: Placebo
Non-alcoholic Steatohepatitis, Fibrosis, Liver Diseases
NASH
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Feasibility Study Using Imaging Biomarkers in Lung Cancer

The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Kemp Kernstine
125019
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02095808
STU 052012-065
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Inclusion Criteria:

• Subjects of all races and ethnic origins over 18 years of age will be recruited.
• Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size.
Exclusion Criteria:

• Patients with a contraindication to MRI examinations will be excluded from this study. Contraindications to MRI examinations include:
• Medically unstable
• Heart failure
• Unstable angina
• Child bearing
• Lactating
• Not a surgical candidate
• Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern.
• Titanium implants, pacemakers
• Poorly controlled diabetes
• Body weight greater than 300 pounds
• Claustrophobic
• Since each patient is receiving a gadolinium based contrast agent intravenously:
• eGFR < 45 mL/min/1.73m2
• Sickle cell disease
• Hemolytic anemia
Procedure: Imaging Biomarkers
Lung Cancer
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JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer (STABLE-MATES)

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Robert Timmerman
69821
All
18 Years to 99 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02468024
STU 022015-069
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Inclusion Criteria:

• Age > 18 years.
• ECOG performance status (PS) 0, 1, or 2.
• Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. Those with ground glass opacities and <50% solid component will be excluded.
• Biopsy confirmed non-small cell lung cancer.
• Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration.
• All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy.
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
• Tumor located peripherally within the lung. NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See below. Patients with non-peripheral (central) tumors are NOT eligible.
• No evidence of distant metastases.
• Availability of pulmonary function tests (PFTs
•spirometry, DLCO, +/- arterial blood gases) within 90 days prior to registration. Patients with tracheotomy, etc, who are physically unable to perform PFTs (and therefore cannot be tested for the Major criteria in 3.1.10 below) are potentially still eligible if a study credentialed thoracic surgeon documents that the patient's health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection).
• Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria
• No prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. No prior lung resection on the ipsilateral side.
• Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test within 60 days prior to registration. Peri-menopausal women must be amenorrheic > 12 months prior to registration to be considered not of childbearing potential.
• No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
• Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:

• evidence of distant metastases
• prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. No prior lung resection on the ipsilateral side.
• pregnant and lactating women
• prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
Procedure: Lung Surgery, Radiation: Radiation therapy
Non-Small Cell Lung Cancer
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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02834013
STU 052017-020
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Inclusion Criteria:

• Patients are eligible under ONE of the following criteria:
• Patients must have histologically confirmed rare cancer and must be able to submit specimens; NOTE: Subsequent to site's Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" to register to this study
• FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to receive EAY131, "NCI-MATCH" therapy
• Patients that do not qualify for one of the histologic cohorts may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email
• Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR
• Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form
• No other prior malignancy is allowed except for the following:
• Adequately managed stage I or II cancer from which the patient is currently in complete remission
• Any other cancer from which the patient has been disease free for one year
• Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
• Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed >= 4 weeks prior to registration
• Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
• Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
• Patients are not eligible if they have had or are planned for solid organ transplant; patients who have received allogeneic hematopoietic stem cell transplant are eligible if:
• The transplant occurred at least 90 days prior to registration,
• Patient has no prior acute graft versus host disease (GVHD), and
• Within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3 consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl measured, wherein the patient did not receive any platelet transfusions within 7 days prior to laboratory assessment
• Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
• Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S1609
• Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab
• Patients must have a Zubrod performance status of 0-2
• Within 28 days prior to registration: ANC >= 1,000/mcL
• Within 28 days prior to registration: Platelets >= 75,000/mcL
• Within 28 days prior to registration: Hemoglobin >= 8 g/dL
• Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin =< 3.0 x IULN
• Within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN
• Within 28 days prior to registration: Serum creatinine =< 2.0 x IULN
• Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight
• Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4 must be obtained
• Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the institutional normal ranges OR cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days prior to registration
• Females of childbearing potential must have negative serum or urine pregnancy test 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; 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
• Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); 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 is responsible for beginning contraceptive measures
• Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
• Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration: 1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3 2. If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; once daily combinations that use pharmacologic boosters may not be used 3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
• Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10mg or equivalent); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Chron's disease), as well as symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years is permitted; short-term steroid premedication for contrast allergy is permitted
• Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)
• Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
• Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration
• Patients must not have symptomatic interstitial lung disease or pneumonitis
• Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration
Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Chordoma, Mucinous Adenocarcinoma, Cervical Adenocarcinoma, Cholangiocarcinoma, Pancreatic Acinar Cell Carcinoma, Lung Carcinoid Tumor, Acinar Cell Carcinoma, Adrenal Cortex Carcinoma, Adrenal Gland Pheochromocytoma, Anal Canal Neuroendocrine Carcinoma, Anal Canal Undifferentiated Carcinoma, Appendix Mucinous Adenocarcinoma, Bladder Adenocarcinoma, Colorectal Squamous Cell Carcinoma, Endometrioid Adenocarcinoma, Esophageal Neuroendocrine Carcinoma, Esophageal Undifferentiated Carcinoma, Extrahepatic Bile Duct Carcinoma, Fallopian Tube Adenocarcinoma, Fibromyxoid Tumor, Gastric Neuroendocrine Carcinoma, Gastric Squamous Cell Carcinoma, Giant Cell Carcinoma, Intestinal Neuroendocrine Carcinoma, Intrahepatic Cholangiocarcinoma, Lung Sarcomatoid Carcinoma, Major Salivary Gland Carcinoma, Malignant Odontogenic Neoplasm, Malignant Peripheral Nerve Sheath Tumor, Malignant Testicular Sex Cord-Stromal Tumor, Metastatic Malignant Neoplasm of Unknown Primary Origin, Mixed Mesodermal (Mullerian) Tumor, Mucinous Cystadenocarcinoma, Nasal Cavity Adenocarcinoma, Nasal Cavity Carcinoma, Nasopharyngeal Carcinoma, Nasopharyngeal Papillary Adenocarcinoma, Nasopharyngeal Undifferentiated Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Undifferentiated Carcinoma, Ovarian Adenocarcinoma, Ovarian Germ Cell Tumor, Ovarian Mucinous Adenocarcinoma, Ovarian Squamous Cell Carcinoma, Pancreatic Neuroendocrine Carcinoma, Paraganglioma, Paranasal Sinus Adenocarcinoma, Paranasal Sinus Carcinoma, Parathyroid Gland Carcinoma, Pituitary Gland Carcinoma, Placental Choriocarcinoma, Placental-Site Gestational Trophoblastic Tumor, Primary Peritoneal High Grade Serous Adenocarcinoma, Pseudomyxoma Peritonei, Scrotal Squamous Cell Carcinoma, Seminal Vesicle Adenocarcinoma, Seminoma, Serous Cystadenocarcinoma, Small Intestinal Adenocarcinoma, Small Intestinal Squamous Cell Carcinoma, Spindle Cell Neoplasm, Squamous Cell Carcinoma of the Penis, Teratoma With Malignant Transformation, Testicular Non-Seminomatous Germ Cell Tumor, Thyroid Gland Carcinoma, Tracheal Carcinoma, Transitional Cell Carcinoma, Ureter Adenocarcinoma, Ureter Squamous Cell Carcinoma, Urethral Adenocarcinoma, Urethral Squamous Cell Carcinoma, Vaginal Adenocarcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, Fallopian Tube Transitional Cell Carcinoma, Ovarian Transitional Cell Carcinoma, Bartholin Gland Transitional Cell Carcinoma, Endometrial Transitional Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Desmoid-Type Fibromatosis, Adenoid Cystic Carcinoma, Gastrointestinal Stromal Tumor, Metaplastic Breast Carcinoma, Rare Disorder, Vulvar Carcinoma, Gastric Undifferentiated Carcinoma
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Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Hak Choy
61863
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT00632853
STU 072010-049
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1. Documentation of Disease 1. Histologically or cytologically documented small cell lung cancer (SCLC) 2. Limited-stage disease patients with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
• Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible
• Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not are not eligible unless they have a negative thoracentesis
• Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray are not eligible 2. Measurable disease
•Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan 3. Prior Treatment 1. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide. 2. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to registration, the patient must have had all of it prior to registration tests as outlined in the protocol and prior to starting their first cycle of chemotherapy. 3. Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy. 4. Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy. 5. Failing to do all of the above will make the patient NOT eligible for CALGB 30610. 6. No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC 7. No prior mediastinal or thoracic radiotherapy 8. Patients with complete surgical resection of disease are not eligible 4. Age Requirement ≥ 18 years of age 5. ECOG Performance Status 0-2 6. Non-pregnant and non-nursing
•No patients that are known to be pregnant or nursing 7. Required Initial Laboratory Values 1. Granulocytes ≥ 1,500/µl 2. Platelet count ≥ 100,000/µl 3. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) 4. AST (SGOT) ≤ 2.0 times ULN 5. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min
Radiation: Standard Radiation Dose Therapy, Drug: cisplatin, Drug: etoposide, Radiation: High Radiation Dose Therapy, Drug: carboplatin
Lung Cancer
limited stage small cell lung cancer
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A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (INCB 24360-202 / MK-3475-037 / KEYNOTE-037/ ECHO-202)

The purpose of this study is to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2 phases, Phase 1 and Phase 2.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Aravind Sanjeevaiah
171563
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02178722
STU 012016-036
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Inclusion Criteria:

• Subjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
• Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
• Life expectancy > 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0
•1.
• Presence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Lugano Classification for subjects with DLBCL.
• Laboratory and medical history parameters within protocol-defined range.
• For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
• For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
• Phase 2 expansion: NSCLC
• Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
• Tumors with epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive treated with a tyrosine kinase inhibitor are permitted; however, subjects should have progressed on or be intolerant to the targeted therapy.
• Subjects must not have received immunotherapy with programmed death receptor-1 (PD-1) or cytotoxic T-lymphocyte antigen (CTLA-4) targeted therapy.
• Phase 2 expansion: Melanoma
• Documentation of V600E-activating BRAF mutation status.
• Prior systemic therapy requirements.
• Melanoma immune checkpoint-naïve: Subjects must not have received immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. Exception: Prior anti−CTLA-4 in the adjuvant setting would be permitted.
• Primary refractory melanoma: Subjects must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and have progressive disease as their best response to treatment that is confirmed 4 weeks later.
• Relapsed melanoma: Subjects must have received prior anti−PD-1 or anti−PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and achieved partial response ore complete response but later have confirmed progressive disease.
• Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
• Ocular melanoma is excluded.
• Phase 2 expansion: Transitional cell carcinoma of the GU tract
• Metastatic or locally advanced and not amenable to curative therapy with disease progression on or after platinum-based chemotherapy or alternative therapy if platinum-based therapy is not appropriate.
• Prior PD-1 or CTLA-4 targeted therapies are excluded
• Phase 2 expansion: SCCHN
• Histologically confirmed metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). Carcinoma of the nasopharynx, salivary gland, or * *Subjects must have received at least 1 prior systemic chemotherapy regimen that must have included a platinum-based therapy.
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Phase 2 expansion: Ovarian cancer
• Subjects with FIGO Stage Ic, Stage II, Stage III, Stage IV, recurrent, or persistent (unresectable) histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma.
• Subjects must have received a platinum-taxane-based regimen as first-line therapy.
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Borderline, low-malignant-potential epithelial carcinoma per histopathology is excluded.
• Phase 2 expansion: Relapsed or refractory DLBCL
• Prior allogeneic stem-cell transplantation is excluded.
• Must have received > or = 1 prior treatment regimen.
• Not a candidate for curative therapy or hematopoietic stem-cell transplantation (either due to disease burden, fitness, or preference).
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Phase 2 expansion: TNBC
• Histologically confirmed breast adenocarcinoma that is unresectable loco regional, or metastatic
• Pathologically confirmed as triple negative, source documented, defined as both of the following:
• Estrogen receptor (ER) and progesterone receptor (PgR) negative.
• Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.
• Subject must have received at least 1 prior systemic regimen for advanced or metastatic disease
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Phase 2 expansion: RCC
• Subjects with histological or cytological confirmation of clear cell RCC.
• Not curable by surgery.
• Subjects must have received prior antiangiogenic therapy.
• Subjects must not have received prior immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
• Phase 2 expansion: MSI high CRC
• Subjects with histological confirmation of locally advanced unresectable or metastatic MSI high CRC.
• MSI status is, respectively, determined by examining CRC tumor.
• Subjects may have received no more than 2 lines of prior therapy for advanced disease.
• Phase 2 expansion: Gastric Cancer
• Must have histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
• Must have progression on or after therapy containing platinum/fluoropyrimidine or refused standard therapy.
• Subjects may have received no more than 2 lines of prior therapy for advanced disease.
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Phase 2 expansion: HCC
• Must have histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
• Barcelona Clinic Liver Cancer (BCLC) Stage C disease (Llovet et al 1999), or BCLC Stage B disease.
• Subjects may have received no more than 2 lines of prior therapy for the advanced disease
• Must have progressed on, refused, or were intolerant of sorafenib.
• The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within 28 days of starting study treatment.
• Prior PD-1 or CTLA-4 targeted therapies are excluded.
• Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
• Females of child-bearing potential and males who use adequate birth control through 120 days post dose.
Exclusion Criteria:

• Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) prior to first dose.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Exception: Prior anti−CTLA-4 in the adjuvant setting for subjects with melanoma would be permitted.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable.
• Has an active autoimmune disease.
• Has evidence of noninfectious pneumonitis that required steroids or current pneumonitis.
• Live vaccine use within 30 days of first dose of study medication.
• Monoamine oxidase inhibitors.
Drug: MK-3475, Drug: INCB024360
Lung Cancer, Endometrial Cancer, Lymphoma, Breast Cancer, Melanoma, Gastric Cancer, Solid Tumors, Head and Neck Cancer, Ovarian Cancer, Hepatocellular Carcinoma (HCC), UC (Urothelial Cancer), Colorectal Cancer (CRC), Renal Cell Carcinoma (RCC)
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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.
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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
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A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03525444
STU 022018-084
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Key
Inclusion Criteria:

• Heterozygous for the F508del mutation (F/MF)
• 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: VX-445, Drug: TEZ, Drug: IVA, Drug: Matched Placebos
Cystic Fibrosis
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Cockroach Nasal Allergen Challenge Pilot

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Rebecca Gruchalla
12819
All
8 Years to 55 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT02710136
STU 012016-026
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Accrual Objective: N=10 adults, 25 children) STUDY INCLUSION CRITERIA:
• Subjects fulfilling all of the following criteria are eligible for enrollment as study participants for Phase 1a and Phase 2: 1. Subject and/or parent guardian must be able to understand and provide informed consent. 2. Male or female adults, 18 through 55 years of age at recruitment (Phase 1) or male or female children, 8‐14 years of age at recruitment (Phase 2). 3. Have a history of asthma for a minimum of 1 year before study entry: 1. A diagnosis of asthma for this study is defined as a reported clinical diagnosis of asthma made by a physician over a year ago. 2. The subject must have persistent asthma defined by the current need for at least 100 microgram (mcg) fluticasone per day or the equivalent of another inhaled corticosteroid. 3. The subject's asthma must be well controlled as defined by:
• A Forced Expiratory Volume in 1 Second (FEV1) ≥ 80% predicted.
• An Asthma Control Test (ACT) score ≥ 20. 4. Are sensitive to German Cockroach as documented by a positive (≥ 3 mm greater than negative control) skin prick test result and a positive German Cockroach specific immunoglobulin E (IgE) (≥0.35 kUA/L). 5. Have no known contraindications to the allergenic extracts or diluents.
• Subjects who meet the following criteria are eligible for enrollment as study participants in Phase 1b after completion of Phase 1a: 1. Their asthma must be well controlled as defined by: 1. A FEV1 ≥ 80% predicted. 2. An Asthma Control Test (ACT) score ≥ 20. 2. The subject tolerated the Nasal Allergen Challenge (NAC) during Phase 1a with no adverse events grade 2 or higher as determined by "Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (published September 2007) for local reactions to study procedures."
• Subjects not eligible for enrollment as study participants in Phase 1b after completion of Phase 1a if any of the following criteria are met: 1. Are pregnant or lactating. 2. Have an asthma severity classification of severe persistent, using the NAEPP classification, as evidenced by at least one of the following: 1. Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid. 2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months. 3. Have been treated with depot corticosteroids within the last 12 months. 4. Have been hospitalized for asthma within the 12 months prior to their participation in Phase1b. 5. Have had an emergency room visit for asthma within the 3 months prior to their participation in Phase 1b. 6. Have had a life‐threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to their participation in Phase 1b. 3. Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to their participation in Phase 1b. 4. Have previously been treated with anti‐IgE therapy in the 12 months prior to their participation in Phase 1b. 5. Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants, nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to the nasal allergen challenge in Phase 1b. 6. Have received an investigational drug in the 30 days prior to their participation in Phase 1b. 7. Have 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 subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 8. Meet any of the Participant Stopping Rules and Withdrawal Criteria during Phase 1a
• The participant elected to withdraw consent from all future study activities, including followup.
• The Investigator no longer believes participation is in the best interest of the participant.
• Serious Adverse Event (SAE) related to investigational product.
• Anaphylactic reaction grade 2 or 3.
• Inability to tolerate the NAC prior to reaching a TNSS ≥8 due to excessive discomfort or symptoms.
• Epistaxis occurring during the Challenge Visit.
• The need to start immunotherapy or any chronic immunosuppressive medications in the period between Phase 1a and Phase 1b.
• Require a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid to maintain asthma control in the period between Phase 1a and Phase 1b.
• Inability to restrict use of antihistamines, nasal steroids, nasal decongestants, nasal anticholinergics or cromolyn prior to the NAC.
• Development of any serious medical illness whose natural history, sequela, or treatment would be worsened or impaired by continuation in the protocol.
• Subject is "lost to follow‐up" 9. The subject's initial TNSS at the Repeat Challenge Visit must be within 1 point of the initial TNSS at the Challenge Visit in Phase 1a. If the participant's initial TNSS is outside the 1 point range, then the participant may be reevaluated for the Repeat Challenge Visit up to 3 additional times. STUDY EXCLUSION CRITERIA: Subjects fulfilling any of the following criteria are not eligible for enrollment in any portion of the study and may not be reassessed. Participants are ineligible if they: 1. Plan to move from the area during the study period. 2. Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined by the grading scale of Brown et al. for anaphylaxis and systemic reactions to study procedures. 3. 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 agent or pose additional risk to the participant. 4. Are using tricyclic antidepressants or beta‐adrenergic blocker drugs (both oral and topical). EXCLUSION CRITERIA SPECIFIC TO STUDY PHASE 1A AND -2:
• Subjects who meet any of these criteria are not eligible for enrollment as study participants in Phase1a and Phase 2: 1. Are pregnant or lactating. Post‐menarcheal females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception). 2. Cannot perform spirometry at Screening. 3. Have an asthma severity classification at Recruitment of severe persistent, using the The National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following: 1. Require a dose of greater than 500mcg of fluticasone per day or the equivalent of another inhaled corticosteroid. 2. Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months or one course within the last 3 months. 3. Have been treated with depot corticosteroids within the last 12 months. 4. Have been hospitalized for asthma within the 12 months prior to recruitment. 5. Have had an emergency room visit for asthma within the 3 months prior to recruitment. 6. Have had a life‐threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment. 4. Have nasal polyps or other major structural abnormalities in their nasal cavities as assessed by anterior rhinoscopy. 5. Have active rhinitis symptoms prior to the nasal allergen challenge, defined as a Baseline Total Nasal Symptom Score(TNSS) >3,with no individual symptom score >1. 6. Do not have access to a phone (needed for scheduling appointments). 7. Have received allergen immunotherapy (Sublingual [SLIT] or Subcutaneous [SCIT]) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study. 8. Have previously been treated with anti‐IgE therapy in the 12 months prior to recruitment. 9. Are currently receiving oral or nasal antihistamines, nasal corticosteroids, nasal decongestants,nasal anticholinergics or cromolyn, which cannot be suspended for the required washout periods prior to skin prick testing and the nasal allergen challenge. 10. Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study. 11. 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.
Biological: Glycerinated German Cockroach Allergenic Extract
Asthma, Cockroach Hypersensitivity
Asthma, Glycerinated German cockroach allergenic extract, Cockroach Nasal Allergen Challenge
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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.
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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
asthma, nested case-control study, difficult-to-control asthma, asthma exacerbations, cold symptoms, gene expression
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Trial of Brigatinib After Treatment With Second-Generation ALK Inhibitors

The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
David Gerber
53487
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02706626
STU 012017-079
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Inclusion Criteria:

• Locally advanced or metastatic non small cell lung cancer that has been cytologically or histologically confirmed
• Anaplastic lymphoma kinase rearrangement based on FDA approved test (e.g., Vysius break apart fluorescence in situ hybridization (FISH) or Immunohistochemistry (IHC) using Ventana)
• Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2
• Age 18 years or older
• Previous treatment with one second generation ALK inhibitor (e.g., ceritinib or alectinib) other than brigatinib
• Brain lesions may be used as target lesions if progressing, are greater than or equal to 10mm in longest diameter and if they were not previously treated with any of the following: whole brain radiation therapy within 3 months; Stereotactic radiosurgery; surgical resection
• Availability of core biopsy of progressive lesion taken within 60 days prior to D1 of treatment under study therapy or willing to undergo tumor biopsy: NOTE:. All subjects must consent to provide tumor blocks or slides. If archival tissue is not available and biopsies to obtain fresh tumor tissue cannot be performed with minimal risk to the subject, subjects may be permitted to enroll on the study with prior approval of the Study PI.
• Recovered from toxicities related to prior anticancer treatment to greater than or equal to grade 2 or baseline with the exception of alopecia
• Have normal QT interval on ECG evaluation QT corrected Fridericia (QTcF) of ≤ 450 ms in males or ≤ 470 ms in females
• Adequate organ function
• At least 1 measurable lesion per RECIST version 1.1
• Negative serum pregnancy test within 7 days of day 1 of treatment in women of childbearing potential
• If fertile, willing to use highly effective form of contraception during the dosing period and for at least 4 months after the dosing period
• Ability to provide signed informed consent and willing and able to comply with all study requirements
Exclusion Criteria:

• History or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis
• Prior treatment with brigatinib
• History of or active significant gastrointestinal bleeding within 3 months
• Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of the study drug
• Received cytotoxic chemotherapy, investigational agents or radiation within 7 days prior to day 1 of study treatment
• Received prior ALK TKI therapy within 7 days prior to day 1 of treatment under study drug. 7 day wash out period is required after prior ALK inhibitor treatment
• Have significant, uncontrolled, or active cardiovascular disease
• Have been diagnosed with another primary malignancy within the past 3 years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer, which are allowed within 3 years)
• Have symptomatic central nervous system (CNS) metastases that are neurologically unstable or require an increasing dose of corticosteroids
• Have active infection requiring intravenous antibiotics
• Pregnant or breastfeeding
• Have any condition or illness that, in the opinion of the investigator would compromise patient safety or interfere with evaluation of the study drug
Drug: brigatinib
Non-Small Cell Lung Cancer
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Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

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Assal Rahimi
115315
Female
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02364557
STU 052016-046
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Inclusion Criteria:

• Pathologically confirmed metastatic breast cancer
• Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
• ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:
• peripheral lung
• osseous (bone)
• spine
• central lung
• abdominal-pelvic(lymph node/adrenal gland)
• liver
• mediastinal/cervical lymph node
• All known disease amenable to metastasis-directed therapy with either SBRT or resection
• NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
• NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
• NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
• Maximum diameter of individual metastasis in any dimension ≤ 5 cm
• There are no restrictions on distance between the metastases
• Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given. If given before study entry, it cannot have exceeded a duration of 12 months at the time of registration. (Note: Sequencing of ablative therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician.)
• The primary tumor site must be controlled prior to registration
• For those who present with synchronous primary and oligometastatic disease: Primary must be controlled prior to registration. The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
• For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
• Appropriate stage for study entry based on the following diagnostic workup:
• History/physical examination within 60 days prior to registration
• Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration
• Zubrod performance status ≤ 2 within 60 days prior to registration
• Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
• Platelets ≥ 50,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
Exclusion Criteria:

• Pathologic evidence of local/regional breast tumor recurrence at the time of registration
• Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported
• Metastases with indistinct borders making targeting not feasible
• NOTE: A potential issue with bone metastases is that they often are not discrete. Since many patients on this protocol will have bone metastases, this will be an important issue. Theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU). Therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
• Prior palliative radiation treatment for metastatic disease (including radiopharmaceuticals)
• Metastases located within 3 cm of the previously irradiated structures:
• Spinal cord previously irradiated to > 40 Gy (delivered in ≤ 3 Gy/fraction)
• Brachial plexus previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in ≤ 3 Gy/fraction)
• Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction)
• Primary tumor irradiated with SBRT
• Metastasis irradiated with SBRT
• Brain metastases
• Exudative, bloody, or cytological proven malignant effusions
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
• Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
Radiation: Stereotactic Radiosurgery, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis
Fatigue, Stage IV Breast Cancer, Pain, Nausea and Vomiting, Dyspnea
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Sym015 (Anti-MET) in Patients With Advanced Solid Tumor Malignancies

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canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02648724
STU 032018-022
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Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Life expectancy >3 months assessed during Screening.
• Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic, and that is refractory to standard therapy or for which no standard therapy is available or accessible.
• If female and of childbearing potential: a negative pregnancy test.
• Male or female: either not of childbearing potential or agreeing to use a medically effective method of contraception as per institutional standards during the trial and for 4 months after the last dose of trial drug.
• Part 1 ONLY: Tumor documented to be KRAS WT by local assessment.
• Part 2 ONLY:
• Measurable disease according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to Cycle 1/Day 1 (C1/D1).
• Basket Cohort ONLY:
• Tumor documented to be KRAS WT by local assessment according to institutional standards. If KRAS WT is not previously documented and if archival tissue is not available for pretrial assessment, patient must be willing to undergo a tumor biopsy to confirm eligibility.
• Confirmed MET-amplification by local assessment.
• No prior therapy with MET-targeting agents (except a subset of patients having received prior therapy with a MET-targeting TKI).
• Willingness to undergo a pre- and post-dosing biopsy (maximum of 2 biopsies) from primary or metastatic tumor site(s) considered safely accessible for biopsy
• NSCLC MET-Amplified Cohort ONLY:
• Documented NSCLC meeting disease criteria as defined per protocol.
• Documented MET-amplification.
• May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs).
• Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the End of Cycle 2 (EOC2) (optional), from a primary or metastatic tumor site considered safely accessible for biopsy.
• NSCLC METex14del Cohort ONLY:
• Documented NSCLC meeting disease criteria as defined per protocol.
• Documented METex14del (tumors need not be MET-amplified).
• May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs).
• Willingness to undergo a pre-dosing biopsy (mandatory unless a recent tumor biopsy is available), and potentially a biopsy at the EOC2 (optional), from a primary or metastatic tumor site considered safely accessible for biopsy.
Exclusion Criteria:

• Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1.
• Immunosuppressive or systemic hormonal therapy within 2 weeks prior to C1/D1, with exceptions.
• Use of hematopoietic growth factors within 2 weeks prior to C1/D1.
• Active second malignancy or history of another malignancy within the last 3 years, with exceptions.
• Central nervous system (CNS) malignancy including primary malignancies of the CNS and known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
• Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy.
• Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure.
• Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to C1/D1, unless adequately treated and stable.
• Active uncontrolled bleeding or a known bleeding diathesis.
• Significant cardiovascular disease or condition.
• Abnormal hematologic, renal or hepatic function.
• Part 2 ONLY:
• Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following the radiotherapy.
• Basket Cohort ONLY:
• Prior therapy with MET-inhibiting agents (exceptions will be a subset of patients that will be entered to the Basket Cohort after having received prior therapy with a MET-targeting TKI).
• Prior therapy with antibody to hepatocyte growth factor (HGF).
• Basket Cohort and NSCLC MET-Amplified Cohort ONLY:
• Tumor status demonstrating MET-polysomy in the absence of MET-amplification, as specified per protocol. Patients in the NSCLC METex14del Cohort with polysomy are eligible.
Drug: Sym015
NSCLC, Non Small Cell Lung Cancer, Oncology, MET Gene Amplification, MET Gene Mutation
Advanced Solid Tumor Malignancies, MET Gene Amplification, MET Amplification, Wild-type, NSCLC, METex14del, Non-Small Cell Lung Carcinoma
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Cockroach Immunotherapy in Children and Adolescents (CRITICAL)

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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)
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AVID100 in Advanced Epithelial Carcinomas

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03094169
STU 012018-026
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Inclusion Criteria (Phase 1): 1. Patients with a documented (histologically- or cytologically-proven) solid tumor epithelial carcinoma that is locally advanced or metastatic 2. Patients with a malignancy that is either refractory to standard therapy, or for which no standard therapy is available 3. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor 4. Phase 1a Dose-Escalation Cohorts: Patients with measurable or non-measurable disease according to RECIST, v1.1 criteria. To include patients reasonably likely to express EGFR. Inclusion Criteria (Phase 2a) 1. Patients with measurable disease according to RECIST, v1.1 criteria. 2. Patients with triple negative breast cancer who are either EGFR 2+ or EGFR 3+ by validated IHC assay. 3. Patients with squamous non-small cell lung cancer who are EGFR 3+ by validated IHC assay. 4. Patients with squamous cell carcinoma of the head and neck who are EGFR 3+ by validated IHC assay. 5. Patients whose malignancy is either refractory to standard therapy, or for which no standard therapy is available 6. Patients whose malignancy is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor Patients to be Excluded (patients must not meet any of the following criteria Phase 1 only) 1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception. 2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required 3. Patients with a malignancy other than that of epithelial origin 4. Patients with hematologic abnormalities at baseline 5. Patients with a significant cardiovascular disease or condition 6. Patients with a significant ocular disease or condition 7. Patients with a significant pulmonary disease or condition 8. History of pneumonia within 6 months prior to the first study drug administration 9. Patients with significant gastrointestinal (GI) abnormalities 10. Patients with non-healing wounds on any part of the body Patients to be Excluded (patients must not meet any of the following criteria Phase 2a only) 1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception. 2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required 3. Patients with a malignancy other than EGFR-overexpressing triple negative breast cancer, squamous histology non-small cell lung cancer, or squamous cell carcinoma of the head and neck. 4. Patients with hematologic abnormalities at baseline 5. Patients with a significant cardiovascular disease or condition 6. Patients with a significant ocular disease or condition 7. Patients with a significant pulmonary disease or condition 8. History of pneumonia within 6 months prior to the first study drug administration 9. Patients with significant gastrointestinal (GI) abnormalities 10. Patients with non-healing wounds on any part of the body 11. Patients without measurable disease according to RECIST v1.1 12. Patients with an active second malignancy within the last 2 years prior to entry Drugs and Other Treatments to be Excluded 1. Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks, 5 plasma half-lives, or twice the duration of the biological effect, whichever is shortest, prior to first study drug administration and during study with the exception of: Nitrosoureas and nitrogen mustard within 6 weeks prior to first study drug administration and during study 2. Any other investigational treatments during study. This includes participation in any medical device or other therapeutic intervention clinical trials. 3. Radiotherapy for target lesions within 4 weeks prior to first study drug administration and during study 4. Herbal preparations or related over-the-counter (OTC) preparations/supplements containing herbal ingredients aimed at treating the underlying malignancy within 2 weeks prior to first study drug administration and during study 5. Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2 weeks prior to first study drug administration and during study 6. Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study. 7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study drug administration and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated
Drug: AVID100 IV
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Solid Tumor, Adult
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Pediatric Adenotonsillectomy for Snoring (PATS)

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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
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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Jade Homsi
175558
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT02568267
STU 012016-042
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Inclusion Criteria:

• Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
•Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria
• For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
• Measurable or evaluable disease
• Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
• Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
•Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
• At least 4 weeks must have elapsed since completion of antibody-directed therapy
• Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
• Adequate organ function as defined per protocol
• Ability to swallow entrectinib intact
• Other protocol specified criteria
Exclusion Criteria:

• Current participation in another therapeutic clinical trial
• Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
•Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
• History of other previous cancer that would interfere with the determination of safety or efficacy
• Incomplete recovery from any surgery
• History of non-pharmacologically induced prolonged QTc interval
• History of additional risk factors for torsade de pointes
• Peripheral neuropathy Grade ≥ 2
• Known active infections
• Active gastrointestinal disease or other malabsorption syndromes
• Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
• Other protocol specified criteria
Drug: Entrectinib
Non-Small Cell Lung Cancer, Breast Cancer, Melanoma, Pancreatic Cancer, Colorectal Cancer, Papillary Thyroid Cancer, Ovarian Cancer, Renal Cell Carcinoma, Cholangiocarcinoma, Neuroendocrine Tumors, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Primary Brain Tumors, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor
Entrectinib, RXDX-101, TrkA, TrkB, TrkC, NTRK1, NTRK2, NTRK3, ROS1, ALK, Trk Fusions, NTRK Gene Rearrangements, ROS1 Fusions, ROS1 Gene Rearrangements, ALK Fusions, ALK Gene Rearrangements, Basket study, Non-small cell lung cancer, Colorectal cancer, Salivary gland cancers, Primary brain tumors, Melanoma, Sarcomas, Papillary thyroid cancer, Renal cell cancer, Pancreatic cancer, Breast cancer, Cholangiocarcinoma, Head & Neck cancers, Ovarian cancer, Neuroendocrine tumors, Anaplastic Large Cell Lymphoma
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Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) (INBUILD®)

The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Craig Glazer
12613
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02999178
STU 042017-023
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Inclusion criteria:
• Written Informed Consent consistent with International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study (and prior to any study procedure including shipment of High Resolution Computer Tomography (HRCT) to reviewer).
• Male or female patients aged >= 18 years at Visit 1.
• Patients with physician diagnosed Interstitial Lung Disease (ILD) who fulfil at least one of the following criteria for Progressive Fibrosing Interstitial Lung Disease (PF-ILD) within 24 months of screening visit (Visit 1) despite treatment with unapproved medications used in clinical practice to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):
• Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of >=10%
• Marginal decline in FVC % pred based on a relative decline of .>=5-<10% combined with worsening of respiratory symptoms
• Marginal decline in FVC % pred based on a relative decline of >=5-<10% combined with increasing extent of fibrotic changes on chest imaging
• Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging [Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus].
• Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10%, performed within 12 months of Visit 1 as confirmed by central readers.
• For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
• Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) [visit 1] ≥ 30% and <80% predicted of normal at Visit 2
• FVC >= 45% predicted at Visit 2 Exclusion criteria:
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN) at Visit 1
• Bilirubin > 1.5 x ULN at Visit 1
• Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula at Visit 1 [Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved].
• Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
• Previous treatment with nintedanib or pirfenidone.
• Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (Visit 1).
• Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD): azathioprine (AZA), cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS) >20mg/day and the combination of OCS+AZA+NAC within 4 weeks of Visit 2, cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of Visit 2. Note: Patients whose Rheumatoid Arthritis (RA)/Connective Tissue Disease (CTD) is managed by these medications should not be considered for participation in the current study unless change in RA/CTD medication is medically indicated (see Inclusion Criteria)
• Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 Guidelines.
• Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
• Previous clinical or echocardiographic evidence of significant right heart failure
• History of right heart catheterization showing a cardiac index <= 2 l/min/m²
• PAH requiring parenteral therapy with epoprostenol/treprostinil
• Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1).
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
• Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
• Cardiovascular diseases, any of the following:
• Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 month of Visit 1
• Myocardial infarction within 6 months of Visit 1
• Unstable cardiac angina within 6 months of Visit 1
• Bleeding risk, any of the following:
• Known genetic predisposition to bleeding.
• Patients who require
• Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)
• High dose antiplatelet therapy. [Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.U. s.c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited].
• History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1.
• Any of the following within 3 months of Visit 1:
• Haemoptysis or haematuria
• Active gastro-intestinal (GI) bleeding or GI
•ulcers
• Major injury or surgery (Investigators judgment).
• Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN at Visit 1.
• History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
• Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
• Patients with peanut allergy.
• Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
• Life expectancy for disease other than ILD < 2.5 years (Investigator assessment).
• Planned major surgical procedures.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Women of childbearing potential* not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information.
• In the opinion of the Investigator, active alcohol or drug abuse.
• Patients not able to understand or follow trial procedures including completion of self-administered questionnaires without help. *A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Drug: Nintedanib, Drug: Placebo
Lung Diseases, Interstitial
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A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children (MUPPITS-2)

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:

• Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent;
• Participant must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol ICAC-30 Manual of Procedures (MOP);
• Participant has had a diagnosis of asthma made >1 year prior to recruitment; --participants who received an asthma diagnosis by a clinician ≤ year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
• Participant has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization);
• At Visit 0 (Screening), have the following requirement for asthma controller medication:
• for participants aged 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and,
• for participants aged 12 years and older, treatment with at least Advair 250/50 mcg DPI one puff twice daily or its equivalent.
• Have peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or via 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:

• Are not able or willing to give written informed consent or comply with 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 pregnant or lactating, or plans to become pregnant during the time of study participation --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, pre-existing parasitic infestation within 6 months of randomization:
• 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 that may impact the quality or interpretation of the data obtained from the study;
• In the event that the participant 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
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A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) (MERU)

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.
Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Saad Khan
136971
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03033511
STU 022017-005
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Inclusion Criteria:

• Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
• At least 3 but no more than 9 weeks between the administration of the last cycle of platinum-based chemotherapy and randomization.
• Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Participants must have adequate bone marrow, renal and hepatic function
• Availability of archived or representative tumor material for assessment of DLL3 expression
Exclusion Criteria:

• Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria
• Any disease-directed radiotherapy (except prophylactic cranial irradiation or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
• Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
Drug: Placebo for dexamethasone, Drug: Placebo for rovalpituzumab tesirine, Drug: Rovalpituzumab tesirine, Drug: Dexamethasone
Small Cell Lung Cancer
Extensive-Stage Small Cell Lung Cancer (ED SCLC), Cancer, Platinum-Based Chemotherapy, Rovalpituzumab tesirine, first-line chemotherapy, (SCLC)
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CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes (CHEC-SC)

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 CFF Patient Registry
• 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 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 EAPs) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)
Cystic Fibrosis
CF, Cystic Fibrosis, Sweat, Sweat chloride, CFTR Modulator
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