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
Overview
- Phase
- Phase 3
- Intervention
- Fluzoparib; Apatinib
- Conditions
- Ovarian Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 690
- Locations
- 1
- Primary Endpoint
- (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •（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.
Exclusion Criteria
- •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.
Arms & Interventions
Safety Lead-in, Doublet Arm
Fluzoparib+Apatinib
Intervention: Fluzoparib; Apatinib
Single Arm
Fluzoparib
Intervention: Fluzoparib
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients
Time Frame: 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
Time Frame: up to 28 days after the last patient of the lead-in phase
Incidence of ≥3 grade treatment related adverse events
Secondary Outcomes
- 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)