A Long Term Safety Study With Atrasentan
Completed · Phase 2/Phase 3
Conditions studied: Prostate Cancer, Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT00127478
- Run by
- Abbott
- People needed
- 166
- Starts
- 2001-07-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2007-11-29
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Prostate Oncology Specialists — Marina del Rey, California, United States
- Western Clinical Research, Inc. — Torrance, California, United States
- South Florida Medical Research — Aventura, Florida, United States
- Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter — New York, New York, United States
- ViaHealth Rochester General Hospital Center for Urology — Rochester, New York, United States
- Oregon Urology Specialist, Division of Clinical Research — Springfield, Oregon, United States
- University of Pittsburgh Department of Urology — Pittsburgh, Pennsylvania, United States
- Cross Cancer Institute — Edmonton, Alberta, Canada
- CroMedia Prime/Prime Trials Vancouver Hospital — Vancouver, British Columbia, Canada
- Ken Janz MD — Burlington, Ontario, Canada
- McMaster Institute of Urology — Hamilton, Ontario, Canada
- McGill University Health Center Royal VIctoria Hosptial — Montreal, Quebec, Canada
- Hoptial de Ranguell Service d'Urologie — Toulouse, Cedex, France
- University Hospital Rotterdam, Department of Urology — Rotterdam, Netherlands
- Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept. — Crewe, United Kingdom
Full record on ClinicalTrials.gov
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