A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Fluzoparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03509636

HR-FZPL-Ⅰb-OC

Details and patient eligibility

About

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.

Full 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.

Enrollment

113 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
Confirmed documented BRCA1/2 mutation;
Received 2~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
Relapsed/progressive disease as confirmed by radiologic assessment；
Have measurable disease as defined by RECIST v1.1.

Exclusion criteria

Any previous treatment with a PARP inhibitor;
Patient with any other malignancy which has been active or treated within the previous 5 years;
Patients with symptomatic uncontrolled brain metastases;
Patients unable to swallow orally administered medication.