Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
NCT ID: NCT02119650
Last Updated: 2018-02-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
76 participants
INTERVENTIONAL
2014-02-11
2016-06-21
Brief Summary
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Detailed Description
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In the second part of the study, participants enrolled and randomized and received pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered was determined from the data produced in the safety run-in phase.
Treatment consisted of repeating 21-day cycles. Participants received infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo was self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, was allowed for participants eligible for maintenance therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ruxolitinib plus Pemetrexed/Cisplatin
Ruxolitinib
5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))
Pemetrexed
500 mg/m\^2 administered as an intravenous infusion over 10 minutes
Cisplatin
75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Placebo plus Pemetrexed/Cisplatin
Placebo
5 mg matching placebo tablets to be administered by mouth
Pemetrexed
500 mg/m\^2 administered as an intravenous infusion over 10 minutes
Cisplatin
75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Interventions
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Ruxolitinib
5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))
Placebo
5 mg matching placebo tablets to be administered by mouth
Pemetrexed
500 mg/m\^2 administered as an intravenous infusion over 10 minutes
Cisplatin
75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 modified Glasgow Prognostic Score (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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard T Kennealey, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Phoenix, Arizona, United States
Fayetteville, Arkansas, United States
Fresno, California, United States
La Jolla, California, United States
San Diego, California, United States
San Francisco, California, United States
Lone Tree, Colorado, United States
Norwich, Connecticut, United States
Southington, Connecticut, United States
Augusta, Georgia, United States
Joliet, Illinois, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Kansas City, Kansas, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
Mount Kisco, New York, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Portland, Oregon, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Ogden, Utah, United States
Leesburg, Virginia, United States
Kennewick, Washington, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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INCB 18424-266
Identifier Type: -
Identifier Source: org_study_id
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