A QT/QTc and Multi-Dose Pharmacokinetic Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

This is an interventional treatment trial for Prostate Neoplasms focused on measuring Prostate neoplasms, Metastatic castration resistant prostate cancer, Abiraterone acetate, CB7630 Read More

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