A Long Term Safety Study With Atrasentan

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Adenocarcinoma; Prostate Cancer

Treatments: Drug: Atrasentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127478

M01-304

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)