A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT02120417
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)
  • Capecitabine — DRUG
    Capecitabine 2000 mg/m\^2 daily given as 1000 mg/m\^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
  • Placebo — DRUG
    5 mg matching placebo tablets to be administered by mouth

Study Details

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.

Key Dates

Start date
May 31, 2014
Status verified
Jan 2018
Primary completion
Feb 29, 2016
Completion
Jan 31, 2017

Study Design

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

Arms

  • Experimental: Treatment A - Capecitabine and ruxolitinib
  • Active Comparator: Treatment B - Capecitabine and placebo

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016. ]

Locations (80)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-ChandlerArizona--
-SedonaArizona--
-La JollaCalifornia--
-Los AngelesCalifornia--
-OxnardCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-Santa MonicaCalifornia--
-AuroraColorado--
-DenverColorado--
-New HavenConnecticut--
-Washington D.C.District of Columbia--
-Fort MyersFlorida--
-HialeahFlorida--
-MiamiFlorida--
-PlantationFlorida--
-St. PetersburgFlorida--
-TampaFlorida--
-AtlantaGeorgia--
-MariettaGeorgia--
-SavannahGeorgia--
-ChicagoIllinois--
-QuincyIllinois--
-SpringfieldIllinois--
-UrbanaIllinois--
-AmesIowa--
-WichitaKansas--
-LouisvilleKentucky--
-Baton RougeLouisiana--
-BaltimoreMaryland--
-DetroitMichigan--
-KalamazooMichigan--
-DuluthMinnesota--
-MinneapolisMinnesota--
-Kansas CityMissouri--
-St LouisMissouri--
-Grand IslandNebraska--
-OmahaNebraska--
-CamdenNew Jersey--
-HackensackNew Jersey--
-FarmingtonNew Mexico--
-AlbanyNew York--
-Johnson CityNew York--
-New YorkNew York--
-The BronxNew York--
-GoldsboroNorth Carolina--
-PinehurstNorth Carolina--
-CantonOhio--
-CincinnatiOhio--
-ClevelandOhio--
-ColumbusOhio--
-MiddletownOhio--
-PortlandOregon--
-BethlehemPennsylvania--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-CharlestonSouth Carolina--
-GreenvilleSouth Carolina--
-ChattanoogaTennessee--
-GermantownTennessee--
-NashvilleTennessee--
-ArlingtonTexas--
-BedfordTexas--
-DallasTexas--
-El PasoTexas--
-Fort WorthTexas--
-HoustonTexas--
-McAllenTexas--
-PlanoTexas--
-TylerTexas--
-OgdenUtah--
-Salt Lake CityUtah--
-FairfaxVirginia--
-NorfolkVirginia--
-RichmondVirginia--
-SalemVirginia--
-SeattleWashington--
-Green BayWisconsin--
-MilwaukeeWisconsin--

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health

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