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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Fluzoparib capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib capsule will be given twice daily orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR by RECIST v1.1 | Objective response rate | every 8 weeks (±7 days) of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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| 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) |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |