Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel
administered as a 1-hour infusion every 3 weeks in combination with oral daily
abiraterone acetate and prednisone in participants with metastatic Castrate-resistant
prostate cancer (CRPC)
- To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone
acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.
Secondary Objectives:
- To characterize the safety profile of the combination
- To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed
combination and dosing schedule
- To assess preliminary antitumor activity of the combination in terms of progression-free
survival, PSA progression free survival and objective response rate, and overall
survival