This study was conducted in subjects in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).
The goal of this clinical trial was to learn if the combination of the drugs cabozantinib and abiraterone works for men that were chemotherapy-naive, bone metastasis CRPC patients. It was designed to learn about the safety of cabozantinib. The main questions are: 1. Does it work and is it safe in men with chemotherapy-naïve bone- metastatic castration resistant CRPC? 2. What was the clinical benefit at different dose levels of the combination of abiraterone and cabozantinib in this patient population? Participants were assigned to one of the four treatment groups: Arm 1. cabozantinib at a dose of 40 mg every day (QD) plus abiraterone with prednisone; Arm 2. cabozantinib at a dose of 20 mg QD plus abiraterone with prednisone; Arm 3. cabozantinib at a dose of 20 mg every other day (QOD) plus abiraterone with prednisone; Arm 4. abiraterone with prednisone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Sedona, Arizona, United States
Unnamed facility
Radiographic Progression Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, as assessed by Independent Radiology Committee (IRC). The sponsor terminated the study early due to business reasons. As such, no data were collected for efficacy analyses.
Time frame: Up to 18 Months
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Tucson, Arizona, United States
Unnamed facility
Oxnard, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Athens, Georgia, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Peoria, Illinois, United States
...and 10 more locations