drugset / Trial / NCT04821622
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
Timeline
- Start
- 2021-05-12
- Primary completion
- 2026-02-18
- Completion
- 2027-08-28
Publications
- Agarwal N, Matsubara N, Azad AA, Saad F, Mateo J, Jiang S, Ye D, Voog E, Shore ND, Cil T, Vulsteke C, Chung HJ, Zschabitz S, Laird AD, Zhang X, Nandoskar P, Chetcuti SF, Wang F, Fizazi K. PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer. N Engl J Med. 2026 May 30. doi: 10.1056/NEJMoa2604126. Online ahead of print.
- Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Future Oncol. 2024 Mar;20(9):493-505. doi: 10.2217/fon-2023-0526. Epub 2023 Oct 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talazoparib | Small molecule | 0.35 mg | — |
| Subject | Talazoparib | Small molecule | 0.5 mg | — |
| Background | Enzalutamide | Other / unclassified | 160 mg | — |