A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
This is an open-label (all people know the identity of the intervention), single-arm,
multicenter (when more than one hospital or medical school team work on a medical research
study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in
participants with prostate cancer who have failed androgen deprivation and docetaxel-based
chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000
milligram (mg) orally (by mouth) once daily after an overnight fast and
prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants
will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and
continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days),
Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated
primarily for prostate specific antigen response according to Prostate Specific Antigen
Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Prostate Specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Day 1 of each cycle (of 28 days each) up to Cycle 12
No
Cougar Biotechnology, Inc. Clinical Trial
Study Director
Cougar Biotechnology, Inc.
United States: Food and Drug Administration
CR016921
NCT00485303
June 2007
October 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
UCLA | Los Angeles, California 90095 |
Beth Israel Hospital | Boston, Massachusetts 02215 |
John Hopkins | Baltimore, Maryland 21205 |
Masachussetts General Hospital Cancer Center | Boston, Massachusetts 02114 |