An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Glucocorticoids

Criteria

Inclusion Criteria:

• Completed 12 cycles of abiraterone acetate under study COU-AA-001

• Last dose of abiraterone acetate within 14 days prior to treatment in this study

• Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment

• Serum potassium level >=3.5 mmol/L

• Eastern Cooperative Oncology Group Performance Status of <3 (Karnofsky Performance Status >=30%)

• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

• Uncontrolled hypertension

• Abnormal liver function

• Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)

• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study