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

Summary

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.

Timeline

Start

2019-08-05

Primary completion

2021-06-22

Completion

2021-06-22

Publications

• Shore N, Mellado B, Shah S, Hauke R, Costin D, Adra N, Cullberg M, Teruel CF, Morris T. A Phase I Study of Capivasertib in Combination With Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer. Clin Genitourin Cancer. 2023 Apr;21(2):278-285. doi: 10.1016/j.clgc.2022.11.017. Epub 2022 Nov 26.

Drugs

Indications