A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17,
20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The
goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone
with placebo plus prednisone in patients with metastatic castration-resistant prostate
cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains
docetaxel. All patients involved in the study will be randomized (assigned by chance) into
one of two arms and will not know what study drug is being given to them. Study drug
randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be
conducted in the United States, Canada, Australia, and the EU. The study will consist of
screening, treatment, and follow-up. In this study, patients will receive study treatment
(abiraterone acetate or placebo) plus prednisone until progression of clinical disease.
Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed
consent. After providing written informed consent, patients will have screening procedures
completed to determine eligibility. Safety evaluations at the screening procedure will
include a physical examination, vital signs, and clinical blood laboratory tests, ECG,
radiographs, urine tests, and recording of any adverse events including details of current
prostate cancer symptoms. Patients will be asked to use a method of birth control with
adequate barrier protection as determined to be acceptable by the principal investigator and
sponsor during the study and for 13 weeks after last study drug administration.
Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as
four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one
hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be
administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study
treatment will continue until disease progression as determined by investigator or when the
patient meets criteria for withdrawal from study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Up to 60 months
No
Cougar Biotechnology, Inc Clinical Trial
Study Director
Cougar Biotechnology, Inc.
United States: Food and Drug Administration
CR016924
NCT00638690
May 2008
October 2012
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Great Falls, Montana 59405 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
McLean, Virginia 22101 | |
Kansas City, Kansas 66160 | |
Omaha, Nebraska 68114 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Honolulu, Hawaii 96813 | |
Las Vegas, Nevada 89109 |