A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

Summary

The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which was determined to be 1mg talazoparib and 75mg/m² temozolomide in the Phase Ib portion of this study.

Timeline

Start

2019-07-11

Primary completion

2025-12-04

Completion

2025-12-04

Publications

• Autio KA, Kyriakopoulos CE, Palyca P, Xiao H, Emamekhoo H, Danila D, Jan M, Catharine V, Riedel E, Devitt M, Laird AD, Scher HI. A phase 1b/2 study of intermittent talazoparib plus temozolomide in patients with metastatic castration-resistant prostate cancer and no mutations in DNA damage response genes. Invest New Drugs. 2025 Aug;43(4):924-932. doi: 10.1007/s10637-025-01580-1. Epub 2025 Sep 4.

Drugs

Indications