NCT01995058

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

A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer (CRPC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Exelixis · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prostate Cancer
• Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	cabozantinib
DRUG	abiraterone
DRUG	prednisone

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-11-26
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

20 sites across 1 country: United States