A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 690
- 试验地点
- 1
- 主要终点
- (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients
研究概览
简要总结
This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.
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
- •（phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
- •（phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
- •（phase 3）Ability to be randomized ≤8 weeks after last dose of platinum
- •（Saftey Lead-in）Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.
排除标准
- •Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
- •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
Safety Lead-in, Doublet Arm
Fluzoparib+Apatinib
干预措施: Fluzoparib; Apatinib (Drug)
Single Arm
Fluzoparib
干预措施: Fluzoparib (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients
时间窗: up to 4 years
Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria
(Safety Lead-in) Incidence of ≥3 grade TRAEs
时间窗: up to 28 days after the last patient of the lead-in phase
Incidence of ≥3 grade treatment related adverse events
次要结局
- PFS by investigator's assessment(up to 4 years)
- Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire(48 months)
- Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.(4 years)
- AEs+SAEs(from the first drug administration to within 30 days for the last treatment dose)
- OS(up to 6 years)
- Patients reported outcome（PROs）assessed by FOSI questionnaire(48 months)