Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Incyte Corporation
- Study ID
- NCT02119650
- Phase
- PHASE2
- Status
- Terminated
Conditions
- NSCLC (Non-small Cell Lung Carcinoma)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUG5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))
- Placebo — DRUG5 mg matching placebo tablets to be administered by mouth
- Pemetrexed — DRUG500 mg/m\^2 administered as an intravenous infusion over 10 minutes
- Cisplatin — DRUG75 mg/m\^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
Study Details
The purpose of this study was 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.
Key Dates
- Start date
- Feb 11, 2014
- Status verified
- Jan 2018
- Primary completion
- Feb 11, 2016
- Completion
- Jun 21, 2016
Study Design
- Enrollment
- 76 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib plus Pemetrexed/Cisplatin
- Active Comparator: Placebo plus Pemetrexed/Cisplatin
Primary Outcome Measure
Overall Survival (OS) [ Time Frame: Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016. ]
Locations (30)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Phoenix | Arizona | - | - |
| - | Fayetteville | Arkansas | - | - |
| - | Fresno | California | - | - |
| - | La Jolla | California | - | - |
| - | San Diego | California | - | - |
| - | San Francisco | California | - | - |
| - | Lone Tree | Colorado | - | - |
| - | Norwich | Connecticut | - | - |
| - | Southington | Connecticut | - | - |
| - | Augusta | Georgia | - | - |
| - | Joliet | Illinois | - | - |
| - | Indianapolis | Indiana | - | - |
| - | Lafayette | Indiana | - | - |
| - | Kansas City | Kansas | - | - |
| - | Detroit | Michigan | - | - |
| - | St Louis | Missouri | - | - |
| - | Reno | Nevada | - | - |
| - | Lebanon | New Hampshire | - | - |
| - | Mount Kisco | New York | - | - |
| - | New York | New York | - | - |
| - | Winston-Salem | North Carolina | - | - |
| - | Canton | Ohio | - | - |
| - | Portland | Oregon | - | - |
| - | Chattanooga | Tennessee | - | - |
| - | Knoxville | Tennessee | - | - |
| - | Memphis | Tennessee | - | - |
| - | Ogden | Utah | - | - |
| - | Leesburg | Virginia | - | - |
| - | Kennewick | Washington | - | - |
| - | Seattle | Washington | - | - |
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