A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer.

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

Details

• Lead Sponsor: Cougar Biotechnology, Inc.
• Treatments: Abiraterone Acetate; Glucocorticoids

Criteria

Inclusion Criteria:

• Men with histologically, cytologically, or biochemically confirmed adenocarcinoma of the prostate

• On-going androgen deprivation with serum testosterone <50 ng/dL (<2.0nmol/L)

• Serum potassium >=3.5 mmol/L

• Eastern Cooperative Oncology Group (ECOG) Performance Status score <2 (Karnofsky Performance Status >=50%)

• No history of adrenal insufficiency or hyperaldosteronism

• Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE (version 3.0) grade of <=1 (chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration)

• No radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of the study drug 1 (SD1) on Day 1

• No surgery or local prostatic intervention within 28 days of the first dose (any clinically relevant sequelae from the surgery must have resolved prior to SD1 on Day 1)

• Agrees to protocol-defined use of effective contraception

• Life expectancy >12 weeks

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

• Protocol-defined laboratory values

• 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)

• Other malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months

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

• 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