Status:
COMPLETED
A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
Lead Sponsor:
Cougar Biotechnology, Inc.
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate...
Detailed Description
This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in ...
Eligibility Criteria
Inclusion
- Histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy
- Prostate specific antigen (PSA) evidence for progressive prostate cancer
- Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir(value) greater than or equal to 4 weeks from treatment withdrawal if treated with flutamide and greater than or equal to 6 weeks if treated with bicalutamide or nilutamide
- Eastern Cooperative Oncology Group (ECOG) performance status score equal to 0 or 1
- Life expectancy of greater than or equal to12 week
Exclusion
- Participants with central nervous system (the brain and spinal cord) disease and/or brain metastases
- No currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer
- Myocardial infarction within the 6 months prior to start of study
- No active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy during protocol treatment
- Major surgery or significant traumatic injury within 4 weeks of start of study
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00473512
Start Date
November 1 2005
End Date
November 1 2008
Last Update
March 27 2014
Active Locations (1)
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1
Sutton, United Kingdom