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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Fluzoparib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Fluzoparib capsule | Drug: Fluzoparib<br>* Fluzoparib capsule will be given twice daily orally<br>* Other names: SHR-3162;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR by RECIST v1.1 | Objective response rate | every 8 weeks (±7 days) of treatment | 

Secondary Outcome Measures

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