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

Phase 3

Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Carcinoma

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.

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients	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	up to 28 days after the last patient of the lead-in phase	Incidence of ≥3 grade treatment related adverse events

Secondary Outcome Measures

Name	Time	Method
PFS by investigator's assessment	up to 4 years	Progression-Free-Survival
Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire	48 months	Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire
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	From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.
AEs+SAEs	from the first drug administration to within 30 days for the last treatment dose	Adverse Events and Serious Adverse Events
OS	up to 6 years	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Patients reported outcome（PROs）assessed by FOSI questionnaire	48 months	Comparison of the Quality of Life in study arms assessed by FOSI questionnaire

Locations (1): Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳
Beijing, Beijing, China

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