Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer

Exclusion Criteria

• •Phase 1
• •Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease prostate specific antigen (PSA) levels (eg, saw palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
• •Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug
• •Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements
• •Prior radiation therapy completed \<4 weeks prior to enrollment
• •Prior chemotherapy for hormone refractory prostate cancer
• •Any currently active second malignancy, other than non-melanoma skin cancer
• •Systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=110 mmHg measured on at least 2 occasions
• •NYHA Class III or IV congestive heart failure
• •Myocardial infarction within the 6 months prior to the first dose of study drug
• •Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled
• •Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
• •Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
• •Phase 2
• •Same as phase 1 with the following addition
• •Abnormal electrocardiogram, including any finding which would interfere with assessment of intervals (patients with long QT syndrome, bundle branch blocks or hemiblocks are prohibited)