A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
This is an open-label study (identity of study drug will be known) to investigate the safety
and efficacy of abiraterone acetate in patients with prostate cancer who have failed taxane
(Docetaxel)-based chemotherapy. Abiraterone acetate 1000 mg will be administered orally (by
mouth) once daily after an overnight fast until disease progression, lack of disease
response after six 28-day cycles of treatment, or unacceptable toxicity is encountered.
Patients will be treated for up to 12 cycles. As of Protocol Amendment 2, all patients will
receive a concurrent low-dose glucocorticoid (such as prednisone/prednisolone). Efficacy and
safety will be monitored throughout the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate specific antigen (PSA) response
PSA decline >=50% according to Prostate Specific Antigen Working Group criteria
Day 1 each cycle, End-of-Study visit
Cougar Biotechnology Clinical Trial
Cougar Biotechnology, Inc.
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|