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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country113 target enrollmentApril 4, 2018

ConditionsOvarian Cancer

InterventionsFluzoparib

DrugsFluzoparib

Overview

Phase: Phase 1
Intervention: Fluzoparib
Conditions: Ovarian Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 113
Locations: 1
Primary Endpoint: ORR by RECIST v1.1
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 4, 2018

End Date

July 23, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Treatment

Fluzoparib capsule

Intervention: Fluzoparib

Outcomes

Primary Outcomes

ORR by RECIST v1.1

Time Frame: every 8 weeks (±7 days) of treatment

Objective response rate

Secondary Outcomes

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