A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer

This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.

The study will be conducted on multiple centers (≤10) in USA and Spain. The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients. The two planned combination treatments during Part A of this study are: Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of data from Part A of this study. The study will include up to approximately 87 evaluable patients, divided among the 4 study parts as follows: Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9 patients per dose level). Part B1: Up to approximately 12 patients. Part A2: Up to approximately 27 patients (up to three dose levels with up to approximately 9 patients per dose level). Part B2: Up to approximately 12 patients.