To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
252
Fluzoparib capsules
Placebo capsule
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
Defined as progression free survival per RECIST 1.1 criteria
Time frame: up to 2 years
Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant
Defined as progression free survival per RECIST 1.1 criteria
Time frame: up to 2 years
Progression free survival(PFS) in relapsed ovarian cancer patients
PFS is Progression-Free-Survival per RECIST 1.1 criteria
Time frame: up to 2 years
Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria
TTP is Time to Progression
Time frame: up to 2 years
Chemotherapy free interval (CFI) CFI
CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)
Time frame: up to 2 years
overall survival(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 3 years
Objective Response Rate
Objective Response Rate complete or partial response per RECIST 1.1 criteria
Time frame: At baseline,at the time point of every 12 weeks, up to 2 years
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Adverse Events(AEs) and Serious Adverse Events (SAEs)
assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.
Time frame: from the first drug administration to within 30 days for the last treatment dose