A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
研究概览
简要总结
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
- •Completion of ≥2 previous platinum-containing regimens
- •Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
- •Ability to be randomized ≤8 weeks after last dose of platinum
排除标准
- •Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
- •Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
- •Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
研究组 & 干预措施
Fluzoparib capsules, 50mg per capsule
Fluzoparib capsules, PO
干预措施: Fluzoparib capsules (Drug)
Placebo capsules, 50mg per capsule
Placebo capsules, PO
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
时间窗: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant
时间窗: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
次要结局
- Progression free survival(PFS) in relapsed ovarian cancer patients(up to 2 years)
- Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria(up to 2 years)
- Chemotherapy free interval (CFI) CFI(up to 2 years)
- Adverse Events(AEs) and Serious Adverse Events (SAEs)(from the first drug administration to within 30 days for the last treatment dose)
- overall survival(OS)(up to 3 years)
- Objective Response Rate(At baseline,at the time point of every 12 weeks, up to 2 years)