Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

Summary

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.

Timeline

Start

2017-06-08

Primary completion

2020-02-01

Completion

2024-08-24

Outcome

Met primary endpoint

paper 18.3 [95% confidence interval (CI), 10.9-not evaluable] versus 5.4 (95% CI, 3.7-5.7) months [hazard ratio (HR) = 0.32; 95% CI, 0.23-0.45; P < 0.0001] PMID 33453391 ↗

Publications

• Wu X, Zhu J, Yin R, Yang J, Liu J, Wang J, Wu L, Liu Z, Gao Y, Wang D, Lou G, Yang H, Zhou Q, Kong B, Huang Y, Chen L, Li G, An R, Wang K, Zhang Y, Yan X, Lu X, Lu W, Hao M, Wang L, Cui H, Chen Q, Abulizi G, Huang X, Tian X, Wen H, Huang Z, Dong J, Zhang C, Hou J, Mirza MR. Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial. EClinicalMedicine. 2024 May 7;72:102629. doi: 10.1016/j.eclinm.2024.102629. eCollection 2024 Jun.
• Wu XH, Zhu JQ, Yin RT, Yang JX, Liu JH, Wang J, Wu LY, Liu ZL, Gao YN, Wang DB, Lou G, Yang HY, Zhou Q, Kong BH, Huang Y, Chen LP, Li GL, An RF, Wang K, Zhang Y, Yan XJ, Lu X, Lu WG, Hao M, Wang L, Cui H, Chen QH, Abulizi G, Huang XH, Tian XF, Wen H, Zhang C, Hou JM, Mirza MR. Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase III trial☆. Ann Oncol. 2021 Apr;32(4):512-521. doi: 10.1016/j.annonc.2020.12.018. Epub 2021 Jan 14.

Drugs

Indications

No indication recorded.