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

• Status: Completed
• Trial end date: 2020-07-23
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Poly(ADP-ribose) Polymerase Inhibitors

Criteria

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.