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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
690
Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
Fluzoparib Orally twice daily
Placebo
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
(Safety Lead-in) Incidence of ≥3 grade TRAEs
Incidence of ≥3 grade treatment related adverse events
Time frame: 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
Time frame: up to 4 years
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 30 days for the last treatment dose
PFS by investigator's assessment
Progression-Free-Survival
Time frame: 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
Time frame: 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
Time frame: 48 months
Patients reported outcome(PROs)assessed by FOSI questionnaire
Comparison of the Quality of Life in study arms assessed by FOSI questionnaire
Time frame: 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.
Time frame: 4 years
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