The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
- Progressive disease before initiating study treatment
- Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Need for current chronic corticosteroid therapy (> 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids)
- Treatment with chemotherapy for the treatment of castration-resistant prostate cancer
Eligible subjects will be assigned by chance (like the flip of a coin) to receive either ipatasertib in combination with abiraterone or placebo in combination with abiraterone. Subjects will have a 50% (1 in 2) chance of receiving ipatasertib in combination with abiraterone, and a 50% (1 in 2) chance of receiving placebo in combination with abiraterone. Each treatment cycle lasts 4 weeks (i.e., 28 days). During each cycle subjects will receive ipatasertib 400 mg or placebo in addition to abiraterone and prednisone.
MRI, CT and Bone scans are required as part of the screening process (28 day window) and at the end of Cycles 2, 4, 6, 9, 12 and every 3 cycles thereafter. This frequency is considered standard of care treatment for metastatic prostate cancer.
The total volume of blood that will be collected during the screening visit is approximately 9 teaspoons (44 milliliters). The total volume of blood that will be collected for study-related analysis will be approximately 93 teaspoons (458 milliliters). This is an estimated amount based on remaining on study treatment for 1 year; it will be more or less depending on how long you remain on study.
Subjects will receive study drugs until it has been determined that the cancer has progressed, until the study treatment becomes intolerable, or until the completion or termination of the study.
Besides blood work and imaging, subjects will undergo ECG testing, physical examinations and will be asked to complete a study diary to record study drug administration and symptoms.