A Long Term Safety Study With Atrasentan
- Conditions
- Prostate CancerAdenocarcinoma
- Registration Number
- NCT00127478
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 166
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events Every 12 weeks Serious adverse events Oncology-related events (OREs) Deaths Study drug exposure Change from baseline in Karnofsky performance status Vital signs Stratification by treatment group from prior study
- Secondary Outcome Measures
Name Time Method Safety and laboratory parameters Every 12 weeks
Trial Locations
- Locations (15)
University of Pittsburgh Department of Urology
🇺🇸Pittsburgh, Pennsylvania, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Prostate Oncology Specialists
🇺🇸Marina Del Rey, California, United States
Hoptial de Ranguell Service d'Urologie
🇫🇷Toulouse, Cedex, France
Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
🇬🇧Crewe, United Kingdom
Western Clinical Research, Inc.
🇺🇸Torrance, California, United States
Oregon Urology Specialist, Division of Clinical Research
🇺🇸Springfield, Oregon, United States
McMaster Institute of Urology
🇨🇦Hamilton, Ontario, Canada
ViaHealth Rochester General Hospital Center for Urology
🇺🇸Rochester, New York, United States
McGill University Health Center Royal VIctoria Hosptial
🇨🇦Montreal, Quebec, Canada
University Hospital Rotterdam, Department of Urology
🇳🇱Rotterdam, Netherlands
Ken Janz MD
🇨🇦Burlington, Ontario, Canada
CroMedia Prime/Prime Trials Vancouver Hospital
🇨🇦Vancouver, British Columbia, Canada
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
🇺🇸New York, New York, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada