Study of Ruxolitinib in Colorectal Cancer Patients

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT02119676
Phase
PHASE2
Status
Terminated

Conditions

  • CRC (Colorectal Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    5 mg tablets to be administered by mouth Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)
  • Regorafenib — DRUG
    Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)
  • Placebo — DRUG
    5 mg matching placebo tablets to be administered by mouth

Study Details

The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

Key Dates

Start date
Mar 31, 2014
Status verified
Jan 2018
Primary completion
Feb 29, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
396 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib plus regorafenib
  • Active Comparator: Placebo plus regorafenib

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016. ]

Locations (57)

FacilityCityStateZIPSite coordinators
-ChandlerArizona--
-GilbertArizona--
-MesaArizona--
-ScottsdaleArizona--
-Los AngelesCalifornia--
-PasadenaCalifornia--
-Santa BarbaraCalifornia--
-AuroraColorado--
-Colorado SpringsColorado--
-DenverColorado--
-Altamonte SpringsFlorida--
-MiamiFlorida--
-OcalaFlorida--
-OrlandoFlorida--
-TampaFlorida--
-NilesIllinois--
-LafayetteIndiana--
-AmesIowa--
-New OrleansLouisiana--
-BaltimoreMaryland--
-Jefferson CityMissouri--
-St LouisMissouri--
-LincolnNebraska--
-OmahaNebraska--
-HendersonNevada--
-Las VegasNevada--
-AlbanyNew York--
-BinghamtonNew York--
-HudsonNew York--
-Johnson CityNew York--
-New YorkNew York--
-The BronxNew York--
-CantonOhio--
-CincinnatiOhio--
-PortlandOregon--
-CharlestonSouth Carolina--
-EasleySouth Carolina--
-GreenvilleSouth Carolina--
-GreerSouth Carolina--
-SumterSouth Carolina--
-ChattanoogaTennessee--
-NashvilleTennessee--
-ArlingtonTexas--
-El PasoTexas--
-Fort WorthTexas--
-HoustonTexas--
-ParisTexas--
-PlanoTexas--
-TylerTexas--
-American ForkUtah--
-BountifulUtah--
-MurrayUtah--
-ProvoUtah--
-Salt Lake CityUtah--
-West JordanUtah--
-RoanokeVirginia--
-VancouverWashington--

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