Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Non-Small-Cell Lung
Intervention: Ruxolitinib (Drug); Placebo (Drug); Pemetrexed (Drug); Cisplatin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Incyte Corporation Official(s) and/or principal investigator(s): Gerard T Kennealey, MD, Study Director, Affiliation: Incyte Corporation
Overall contact: Incyte Corporation Call Center, Phone: 1-855-463-3463
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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.Part 2: Overall Survival (OS)
Secondary outcome: Progression-free survival (PFS)Objective Response Rate Duration of Response Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Incyte Corporation Call Center, Phone: 1-855-463-3463
Phoenix, Arizona, United States; Recruiting
Fayetteville, Arkansas, United States; Recruiting
Fresno, California, United States; Recruiting
La Jolla, California, United States; Recruiting
San Diego, California, United States; Recruiting
San Francisco, California, United States; Recruiting
Lone Tree, Colorado, United States; Recruiting
Norwich, Connecticut, United States; Recruiting
Southington, Connecticut, United States; Recruiting
Augusta, Georgia, United States; Recruiting
Joilet, Illinois, United States; Recruiting
Indianapolis, Indiana, United States; Recruiting
Lafayette, Indiana, United States; Recruiting
Kansas City, Kansas, United States; Recruiting
Detroit, Michigan, United States; Recruiting
Saint Louis, Missouri, United States; Recruiting
Reno, Nevada, United States; Recruiting
Lebanon, New Hampshire, United States; Recruiting
Mount Kisco, New York, United States; Recruiting
New York, New York, United States; Recruiting
Winston-Salem, North Carolina, United States; Recruiting
Canton, Ohio, United States; Recruiting
Portland, Oregon, United States; Recruiting
Chattanooga, Tennessee, United States; Recruiting
Knoxville, Tennessee, United States; Recruiting
Memphis, Tennessee, United States; Recruiting
Ogden, Utah, United States; Recruiting
Leesburg, Virginia, United States; Recruiting
Kennewick, Washington, United States; Recruiting
Seattle, Washington, United States; Recruiting
Additional Information
Starting date: March 2014
Last updated: May 28, 2015
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