A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Exelixis
Study ID
NCT01865747
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

Key Dates

Start date
Jun 30, 2013
Status verified
Apr 2021
Primary completion
May 22, 2015
Completion
Jan 15, 2021

Study Design

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

Arms

  • Experimental: Cabozantinib (XL184)
    Cabozantinib (XL184) 60 mg tablet once daily.
  • Active Comparator: Everolimus (Afinitor)
    Everolimus (Afinitor) 10 mg tablet once daily.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months. ]

Locations (59)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-AnchorageAlaska99503-
-GilbertArizona85234-
-ScottsdaleArizona85259-
-TucsonArizona85724-
-DuarteCalifornia91010-
-La JollaCalifornia92093-
-Los AngelesCalifornia90048-
-Los AngelesCalifornia90095-
-VallejoCalifornia94589-
-AuroraColorado80045-
-DenverColorado80218-
-New HavenConnecticut06520-
-Washington D.C.District of Columbia20007-
-Boca RatonFlorida33486-
-MiamiFlorida33136-
-MiamiFlorida33176-
-OrlandoFlorida06520-
-TampaFlorida33612-
-ChicagoIllinois60611-
-ChicagoIllinois60612-
-ChicagoIllinois60637-
-Iowa CityIowa52242-
-WestwoodKansas66205-
-BaltimoreMaryland21201-
-BaltimoreMaryland21287-
-BostonMassachusetts02215-
-Ann ArborMichigan48109-
-DetroitMichigan48201-
-DetroitMichigan48202-
-RochesterMinnesota55905-
-St LouisMissouri63110-
-Las VegasNevada89148-
-AlbanyNew York12206-
-New YorkNew York10065-
-DurhamNorth Carolina22710-
-ClevelandOhio44106-
-ClevelandOhio44195-
-ColumbusOhio43210-
-PortlandOregon97213-
-PortlandOregon97239-
-PhiladelphiaPennsylvania19111-
-PittsburghPennsylvania15232-
-CharlestonSouth Carolina29425-
-KnoxvilleTennessee37920-
-MemphisTennessee38120-
-NashvilleTennessee37203-
-NashvilleTennessee37232-
-AustinTexas78731-
-BedfordTexas76022-
-DallasTexas75246-
-Fort WorthTexas76104-
-HoustonTexas77024-
-HoustonTexas77030-
-San AntonioTexas78229-
-Salt Lake CityUtah84112-
-SeattleWashington98109-
-VancouverWashington98684-
-YakimaWashington98902-

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