A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

Phase 3 Active not recruiting 404 enrolled Impact Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment

Timeline

Start: 2019-12-24
Primary completion: 2023-03-16
Completion: 2026-06-30

Outcome

Met primary endpoint

paper the median progression-free survival was not reached with senaparib and was 13.6 months with placebo (hazard ratio 0.43, 95% confidence interval 0.32-0.58; P < 0.0001). PMID 38750351 ↗

release “随机、双盲、安慰剂对照、多中心III期临床研究（FLAMES研究，NCT04169997）已完成方案预设的期中分析。独立数据监查委员会（IDMC）判定研究的主要终点达到方案预设的优效界值。” junshipharma.com ↗

Publications

Wu X, Liu J, Wang J, Wang L, Lin Z, Wang X, Zhu J, Kong B, Fei J, Tang Y, Xia B, Liang Z, Wang K, Huang Y, Zheng H, Lin A, Jiang K, Wang W, Wang X, Lou G, Pan H, Yao S, Li G, Hao M, Cai Y, Chen X, Yang Z, Chen Y, Wen H, Qu P, Xu C, Hsieh CY; FLAMES Investigators. Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial. Nat Med. 2024 Jun;30(6):1612-1621. doi: 10.1038/s41591-024-03003-9. Epub 2024 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IMP4297	Unknown	100 mg	Oral