Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Exelixis
Study ID
NCT01605227
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • cabozantinib — DRUG
    Tablets taken orally once-daily
  • prednisone — DRUG
    Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Study Details

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

Key Dates

Start date
Jul 31, 2012
Status verified
Feb 2018
Primary completion
Sep 30, 2014
Completion
Mar 31, 2015

Study Design

Enrollment
1,028 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cabozantinib
    Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
  • Active Comparator: prednisone
    Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: OS was measured from the time of randomization until 614 events, approximately 24 months after study start ]

Locations (77)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35205-
-AnchorageAlaska99508-
-PhoenixArizona85016-
-ScottsdaleArizona85255-
-TucsonArizona85710-
-JonesboroArkansas72401-
-DuarteCalifornia91010-
-HighlandCalifornia92346-
-La JollaCalifornia92093-
-Los AngelesCalifornia90033-
-MontebelloCalifornia90640-
-OrangeCalifornia92868-
-Palo AltoCalifornia94301-
-Rancho MirageCalifornia92270-
-San MarcosCalifornia92069-
-St. HelenaCalifornia94574-
-VallejoCalifornia94589-
-AuroraColorado80045-
-New HavenConnecticut06520-
-SouthingtonConnecticut06489-
-Miami BeachFlorida33140-
-OcalaFlorida34471-
-OrlandoFlorida32806-
-TampaFlorida33612-
-TitusvilleFlorida32796-
-WellingtonFlorida33449-
-West Palm BeachFlorida33401-
-AthensGeorgia30607-
-AtlantaGeorgia30318-
-MariettaGeorgia30060-
-GalesburgIllinois61401-
-NilesIllinois60714-
-AmesIowa50010-
-Sioux CityIowa51101-
-WichitaKansas67214-
-HazardKentucky41701-
-LouisvilleKentucky40202-
-BrewerMaine04412-
-BaltimoreMaryland21201-
-BethesdaMaryland20817-
-TowsonMaryland21204-
-BostonMassachusetts02114-
-BostonMassachusetts02118-
-MethuenMassachusetts01844-
-DetroitMichigan48202-
-WyomingMichigan49509-
-MinneapolisMinnesota55455-
-Jefferson CityMissouri65109-
-SpringfieldMissouri65804-
-LincolnNebraska68506-
-OmahaNebraska68130-
-HackensackNew Jersey07601-
-LawrencevilleNew Jersey08648-
-AlbanyNew York12208-
-Garden CityNew York11530-
-New YorkNew York10065-
-PinehurstNorth Carolina28374-
-BismarckNorth Dakota58501-
-CincinnatiOhio45219-
-ColumbusOhio43221-
-PortlandOregon97227-
-Bryn MawrPennsylvania19010-
-HersheyPennsylvania17033-
-LancasterPennsylvania17604-
-GreenvilleSouth Carolina29615-
-ChattanoogaTennessee37421-
-AmarilloTexas79106-
-BedfordTexas76022-
-HoustonTexas77024-
-LaredoTexas78041-
-San AntonioTexas78217-
-Salt Lake CityUtah84112-
-BurlingtonVermont05405-
-FairfaxVirginia22031-
-Newport NewsVirginia23601-
-SpokaneWashington99204-
-Green BayWisconsin54311-

Find similar trials in Birmingham, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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