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Brief Title: A Study of Fluzoparib(SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer
Official Title: An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib(SHR3162)in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
Study ID: NCT03509636
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China