Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Exelixis
Study ID
NCT01995058
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • cabozantinib — DRUG
  • abiraterone — DRUG
  • prednisone — DRUG

Study Details

This study was conducted in subjects in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).

Key Dates

Start date
Feb 28, 2014
Status verified
Dec 2025
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Arm 1: Cabozantinib 40 mg + abiraterone with prednisone
    Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone
  • Experimental: Arm 2: Cabozantinib 20 mg + abiraterone and prednisone
    Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone
  • Experimental: Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone
    Cabozantinib 20 mg every other day with abiraterone and prednisone
  • Active Comparator: Arm 4: Abiraterone and prednisone only
    Abiraterone with prednisone

Primary Outcome Measure

Radiographic Progression Free Survival (PFS) [ Time Frame: Up to 18 Months ]

Locations (20)

FacilityCityStateZIPSite coordinators
-ScottsdaleArizona85258-
-SedonaArizona86336-
-TucsonArizona85710-
-OxnardCalifornia93030-
-San DiegoCalifornia92108-
-AuroraColorado80012-
-AuroraColorado80045-
-AthensGeorgia30607-
-AtlantaGeorgia30318-
-PeoriaIllinois61615-
-WichitaKansas67214-
-Las VegasNevada89148-
-RaleighNorth Carolina27607-
-TualatinOregon97062-
-CharlestonSouth Carolina29414-
-GreenvilleSouth Carolina29605-
-Myrtle BeachSouth Carolina29572-
-DallasTexas75246-
-HoustonTexas77024-
-Salt Lake CityUtah84112-

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