Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||carcinoma, non-small-cell lung|
|Treatments||ruxolitinib, placebo, pemetrexed, cisplatin|
|Targets||JAK, JAK1, JAK2|
|Start date||March 2014|
|End date||February 2016|
|Trial size||91 participants|
|Trial identifier||NCT02119650, INCB 18424-266|
The purpose of this study is to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Phoenix, AZ||not available||no longer recruiting|
|Scottsdale, AZ||Mayo Clinic in Arizona||no longer recruiting|
|Fayetteville, AR||not available||no longer recruiting|
|Fresno, CA||not available||no longer recruiting|
|La Jolla, CA||not available||no longer recruiting|
|San Diego, CA||not available||no longer recruiting|
|San Diego, CA||University of California San Diego||no longer recruiting|
|San Francisco, CA||not available||no longer recruiting|
|Lone Tree, CO||not available||no longer recruiting|
|Norwich, CT||not available||no longer recruiting|
|Southington, CT||not available||no longer recruiting|
|Tampa, FL||Moffitt Cancer Center||terminated|
|Augusta, GA||not available||no longer recruiting|
|Joilet, IL||not available||no longer recruiting|
|Indianapolis, IN||not available||no longer recruiting|
|Indianapolis, IN||Indiana University / Melvin and Bren Simon Cancer Center||no longer recruiting|
|Lafayette, IN||not available||no longer recruiting|
|Kansas City, KS||not available||no longer recruiting|
|Kansas City, KS||University of Kansas Cancer Center||no longer recruiting|
|Detroit, MI||not available||no longer recruiting|
|Detroit, MI||Wayne State University / Karmanos Cancer Institute||terminated|
|Saint Louis, MO||not available||no longer recruiting|
|Saint Louis, MO||Siteman Cancer Center at Washington University||no longer recruiting|
|Reno, NV||not available||no longer recruiting|
|Lebanon, NH||not available||no longer recruiting|
|Lebanon, NH||Dartmouth Hitchcock Medical Center||no longer recruiting|
|Albuquerque, NM||University of New Mexico Cancer Center||no longer recruiting|
|Bronx, NY||Montefiore Medical Center-Weiler Hospital||no longer recruiting|
|Mount Kisco, NY||not available||no longer recruiting|
|New York, NY||not available||no longer recruiting|
|New York, NY||Columbia University / Herbert Irving Cancer Center||no longer recruiting|
|Winston-Salem, NC||not available||no longer recruiting|
|Canton, OH||not available||no longer recruiting|
|Portland, OR||not available||no longer recruiting|
|Chattanooga, TN||not available||no longer recruiting|
|Knoxville, TN||not available||no longer recruiting|
|Memphis, TN||not available||no longer recruiting|
|San Antonio, TX||University of Texas Health Science Center at San Antonio||completed|
|Ogden, UT||not available||no longer recruiting|
|Leesburg, VA||not available||no longer recruiting|
|Kennewick, WA||not available||no longer recruiting|
|Seattle, WA||not available||no longer recruiting|
|Seattle, WA||Fred Hutch / University of Washington Cancer Consortium||no longer recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Part 1: Determination of the dose of ruxolitinib that is safe and tolerable in combination with pemetrexed/cisplatin as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort.
time frame: Baseline through Day 21
Part 2: Overall Survival (OS)
time frame: Randomization until death due to any cause. Approximately 30 months.
Progression-free survival (PFS)
time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 30 months.
Objective Response Rate
time frame: Baseline through end of study. Approximately 30 months.
Duration of Response
time frame: Baseline through end of study. Approximately 30 months.
Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
time frame: Baseline through approximately 30 days post treatment discontinuation. Assessed after approximately 30 months.
Male or female participants at least 18 years old.
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy). - Radiographically measurable or evaluable disease. - Life expectancy of at least 12 weeks. - Tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma). - An mGPS of 1 or 2 as defined below: *Criteria: - C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1 - C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit. Exclusion Criteria: - Squamous or mixed histology (eg, adenosquamous) NSCLC - Previous systemic therapy for advanced or metastatic disease. - Known active central nervous system (CNS) metastases. - Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. - Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment. - Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
|Official title||A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent|
|Description||The study consists of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 subjects each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Subjects in the safety run-in will receive open-label ruxolitinib and pemetrexed and cisplatin. In the second part of the study, subjects will be enrolled and randomized to receive pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered will be determined from the data produced in the safety run-in phase. Treatment will consist of repeating 21-day cycles. Subjects will receive infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo will be self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, will be allowed for subjects eligible for maintenance therapy.|
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