Study of Ruxolitinib in Pancreatic Cancer Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT01423604
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
  • Ruxolitinib — DRUG
    Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)
  • Placebo — DRUG
    Placebo matching ruxolitinib

Study Details

The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.

Key Dates

Start date
Jul 31, 2011
Status verified
Jan 2018
Primary completion
Jun 30, 2013
Completion
Nov 30, 2016

Study Design

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

Arms

  • Experimental: Capecitabine and ruxolitinib
  • Placebo Comparator: Capecitabine and placebo

Primary Outcome Measure

Overall Survival [ Time Frame: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months). ]

Locations (39)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Hot SpringsArkansas--
-BurbankCalifornia--
-Los AngelesCalifornia--
-Santa MonicaCalifornia--
-DenverColorado--
-StamfordConnecticut--
-Boynton BeachFlorida--
-Fort MyersFlorida--
-St. PetersburgFlorida--
-Arlington HeightsIllinois--
-Elks Grove VillageIllinois--
-IndianapolisIndiana--
-Sioux CityIowa--
-LexingtonKentucky--
-LouisvilleKentucky--
-WorcesterMassachusetts--
-Ann ArborMichigan--
-DetroitMichigan--
-Grand RapidsMichigan--
-NoviMichigan--
-MinneapolisMinnesota--
-St LouisMissouri--
-Voorhees TownshipNew Jersey--
-AlbuquerqueNew Mexico--
-Lake SuccessNew York--
-DurhamNorth Carolina--
-HickoryNorth Carolina--
-CantonOhio--
-DaytonOhio--
-TulsaOklahoma--
-BendOregon--
-PortlandOregon--
-DanvillePennsylvania--
-PittsburghPennsylvania--
-KnoxvilleTennessee--
-San AntonioTexas--
-RichmondVirginia--
-Green BayWisconsin--

Find similar trials in Birmingham, AL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology

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