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This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-in or Parallel, Fluzoparib+Apatinib | Experimental | Participants will receive Fluzoparib-Apatinib combination until progression |
|
| Fluzoparib monotherapy | Active Comparator | Participants will receive Fluzoparib monotherapy until progression |
|
| Exploratory cohort: Fluzoparib+Apatinib | Other | Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib+Apatinib | Drug | Fluzoparib-Apatinib combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle | up to 28 days | |
| (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib | up to 28 days | |
| (Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients | Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment | Assessed up to a maximum of 20 months |
| (Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients | Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment | Assessed up to a maximum of 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last treatment dose |
| Progression free survival (PFS) | Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
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| Fluzoparib | Drug | Fluzoparib monotherapy |
|
| Fluzoparib+Apatinib | Drug | Fluzoparib-Apatinib combination |
|
| up to 20 months |
| Disease control rate (DCR) | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 | up to 20 months |
| Duration of response (DoR) | Time from documentation of tumor response to disease progression assessed among patients who had an objective response | up to 20 months |
| Response rate by RECIST 1.1 criteria | up to 20 months |
| Response rate by GCIG CA125 | up to 20 months |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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