XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized, open-label, multi-center study comparing the safety and efficacy of
XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone
refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen.
The primary objective is overall survival. Secondary objectives include progression free
survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain
response/progression, overall safety, and pharmacokinetics. Patients will be treated until
disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients
will have long-term follow-up for a maximum of up to 2 years.