An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.

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

Details

• Lead Sponsor: Cougar Biotechnology, Inc.
• Treatments: Abiraterone Acetate; Androgens; Docetaxel; Glucocorticoids; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells that line certain internal organs and that have secretory properties) of the prostate, but not with neuroendocrine differentiation or of small cell histology

• Before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel

• Documented prostate-specific antigen (PSA) progression according to PSA working group eligibility criteria with a PSA greater than 5 nanogram per milliliter (ng/mL)

• Ongoing androgen deprivation with serum testosterone level of less than 50 nanogram per deciliter (ng/dL)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2 (Karnofsky Performance Status greater than or equal 50 percentage)

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy

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

• Uncontrolled hypertension

• 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 (participants 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 before to enrollment and after consultation with a cardiologist to insure that the disease is stable)

• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication