A Long Term Safety Study With Atrasentan

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Atrasentan

Criteria

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.