Abbreviations
ABI+pred+ADT
PLB+pred+ADT
797
398
Phase:
3
Double blind
Prostate
mCRPC
meta
L2
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies - At least one chemotherapy must have contained docetaxel - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 - Medical or surgical castration with testosterone < 50 ng/dL - Adequate bone marrow, hepatic and renal function - Potassium ≥ 3.5 mmol/L - Able to swallow the study drug whole as a tablet - Informed Consent
- More than two prior cytotoxic chemotherapy regimens - Prior Ketoconazole for prostate cancer - Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer - Uncontrolled hypertension - Active or symptomatic viral hepatitis or chronic liver disease - History of pituitary or adrenal dysfunction - Clinically significant heart disease - Other malignancy - Known brain metastasis - GI disorder affecting absorption - Not willing to use contraception