Status:
COMPLETED
A Long Term Safety Study With Atrasentan
Lead Sponsor:
Abbott
Conditions:
Prostate Cancer
Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Greater than or equal to 18 years, inclusive;
- Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
- Karnofsky Performance Score greater than or equal to 60;
- Adequate hematologic function and liver function tests;
- No New York Heart Association (NYHA) class greater than or equal to 2.
Exclusion
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00127478
Start Date
July 1 2001
End Date
June 1 2007
Last Update
November 29 2007
Active Locations (15)
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1
Prostate Oncology Specialists
Marina del Rey, California, United States, 32589
2
Western Clinical Research, Inc.
Torrance, California, United States, 90505
3
South Florida Medical Research
Aventura, Florida, United States, 33180
4
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
New York, New York, United States, 10003