Status:
COMPLETED
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Lead Sponsor:
Cougar Biotechnology, Inc.
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who ...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status \<= 2
- Medical or surgical castration with testosterone \< 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium \>= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1195 Patients enrolled
Trial Details
Trial ID
NCT00638690
Start Date
May 1 2008
End Date
October 1 2012
Last Update
April 30 2014
Active Locations (127)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Beverly Hills, California, United States
4
Duarte, California, United States