A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Drug: Fluzoparib; Apatinib
* Drug: Fluzoparib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety Lead-in, Doublet Arm<br>Fluzoparib+Apatinib | Drug: Fluzoparib; Apatinib<br>* Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily<br>|
| Experimental: Single Arm<br>Fluzoparib | Drug: Fluzoparib<br>* Fluzoparib Orally twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Safety Lead-in) Incidence of ≥3 grade TRAEs | Incidence of ≥3 grade treatment related adverse events | up to 28 days after the last patient of the lead-in phase | 
| (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients | Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last treatment dose | 
| PFS by investigator's assessment | Progression-Free-Survival | up to 4 years | 
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 6 years | 
| Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire | Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire | 48 months | 
| Patients reported outcome（PROs）assessed by FOSI questionnaire | Comparison of the Quality of Life in study arms assessed by FOSI 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. | 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 |