A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Documented metastatic disease

- Has not received chemotherapy or has no more than one line of cytotoxic chemotherapy
or biologic therapy for treatment of castration resistant prostate cancer (CRPC)

- Documented prostate specific antigen (PSA) progression as assessed by the
investigator according to Prostate Cancer Working Group 2 (PCWG2) criteria despite
medical or surgical castration, or prostate cancer progression documented by
radiographic progression according to Response Evaluation Criteria In Solid Tumors
(RECIST) criteria

- Surgically or medically castrated with testosterone levels of <50 ng/dL (<2.0 nM)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1

- Agrees to protocol-defined use of effective contraception

- Protocol-specified laboratory parameters

Exclusion Criteria:

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

- Abnormal liver function

- Uncontrolled hypertension

- Active or symptomatic viral hepatitis or chronic liver disease

- Known brain metastasis

- History of pituitary or adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
measurement of < 50 % at baseline

- Diagnosis of cardiac arrhythmia

- Treatment with anti-arrhythmic drugs primarily for cardiac arrhythmia

- Abnormal electrocardiogram

- Other malignancy (except non-melanoma skin cancer, that is active or has a ≥ 30%
probability of recurrence within 24 months) History of gastrointestinal disorders
(medical disorders or extensive surgery) which may interfere with the absorption of
the study drug

- Surgery or local prostatic intervention within 30 days of the first dose

- Radiotherapy or immunotherapy within 30 days, or single fraction of palliative
radiotherapy within 14 days of administration of Cycle 1 Day 1

- Any acute toxicities due to prior therapy that have not resolved to a NCI CTCAE
(version 3.0) grade of <=1

- More than one prior cytotoxic chemotherapy or biologic therapy for treatment of CRPC

- Prior chemotherapy with mitoxantrone or other anthracyclines (ie, doxorubicin,
daunomycin, epirubicin and idarubicin)

- Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of Cycle 1 Day 1

- Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1 Day 1

- Prior bicalutamide (Casodex), nilutamide (Nilandron, Anandron) within 6 weeks of
Cycle 1 Day 1

- Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700)

- Previous investigational antiandrogens (eg, MDV3100, BMS-641988)

- Patients receiving anti-coagulant therapy

- 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