Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Summary

The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents.

Timeline

Start

2018-12-28

Primary completion

2019-03-17

Completion

2022-12-28

Publications

• Itamochi H, Takeshima N, Hamanishi J, Hasegawa K, Matsuura M, Miura K, Nagao S, Nakai H, Tanaka N, Tokunaga H, Nishio S, Watari H, Yokoyama Y, Kase Y, Sumino S, Kato A, Suri A, Yasuoka T, Takehara K. Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study. J Gynecol Oncol. 2024 Sep;35(5):e115. doi: 10.3802/jgo.2024.35.e115. Epub 2024 Jul 17.
• Takehara K, Matsumoto T, Hamanishi J, Hasegawa K, Matsuura M, Miura K, Nagao S, Nakai H, Tanaka N, Tokunaga H, Ushijima K, Watari H, Yokoyama Y, Kase Y, Sumino S, Suri A, Itamochi H, Takeshima N. Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer. J Gynecol Oncol. 2021 Mar;32(2):e21. doi: 10.3802/jgo.2021.32.e21. Epub 2021 Jan 6.

Drugs

Indications