A Long Term Safety Study With Atrasentan

A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

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.

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.