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

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Fluzoparib

• Registration Number: NCT03509636
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2018-02-25
• Study Start: 2018-04-04
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-26
• Primary Completion: 2019-08-26
• Study Completion: 2020-07-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Fluzoparib	Fluzoparib capsule

Primary Outcome Measures

Name	Time	Method
ORR by RECIST v1.1	every 8 weeks (±7 days) of treatment	Objective response rate

Secondary Outcome Measures

Name	Time	Method
Response rate by GCIG CA-125	every 8 weeks (±7 days) of treatment expected to last for ~2 years	Response rate per GCIG CA-125
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications	Every day starting with signing of consent until 30 days after discontinuation of treatment	per CTC AE 4.03
DoR	study data collection expected to last for ~2 years	Duration of response
PFS	expected to last for ~2 years	Progression free survival
OS	study data collection expected to last for ~2 years	Overall suvival
Trough (Cmin) level of fluzoparib concentrations	Cycle 1 to cycle 4(each cycle is 28 days)	Cssmin of fluzoparib concentrations

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China