This is a multicenter, open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib (SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer.
Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Fluzoparib capsule will be given twice daily orally
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
ORR by RECIST v1.1
Objective response rate
Time frame: every 8 weeks (±7 days) of treatment
DoR
Duration of response
Time frame: study data collection expected to last for ~2 years
PFS
Progression free survival
Time frame: expected to last for ~2 years
Response rate by GCIG CA-125
Response rate per GCIG CA-125
Time frame: every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS
Overall suvival
Time frame: study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
per CTC AE 4.03
Time frame: Every day starting with signing of consent until 30 days after discontinuation of treatment
Trough (Cmin) level of fluzoparib concentrations
Cssmin of fluzoparib concentrations
Time frame: Cycle 1 to cycle 4(each cycle is 28 days)
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