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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib + Apatinib | Experimental | Fluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib either at 40,60,80mg twice daily,capsule oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The type and incidence of adverse events [safety and tolerability] | Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03 | From screening up to 28 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | [Complete response + Partial response (CR+PR)] based on RECIST 1.1 | 24 months (approx) from the start of treatment |
| Disease Control Rate (DOR) | [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hosptial | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37775744 | Derived | Liu Y, Wang W, Yin R, Zhang Y, Zhang Y, Zhang K, Pan H, Wang K, Lou G, Li G, Zhang R, Li K, Rao J, Zhang B, Wang Y, Wang Q, Gao Y, Li H. A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis. BMC Med. 2023 Sep 29;21(1):376. doi: 10.1186/s12916-023-03046-8. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| C553458 | apatinib |
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| Apatinib | Drug | Apatinib at 250mg once daily, tablet oral |
|
| 24 months (approx) from the start of treatment |
| Time to Progression (TTP) | The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients | From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months |
| Overall Survival (OS) | Time from start of fluzoparib treatment until death due to any cause | From Cycle 1, Day 1 until death or up to 48 months (approx) |
| Cmax | Maximum Plasma Concentration | From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment |
| T1/2 (Half-life) | The time required for the plasma concentration of a drug to be reduced by 50% | From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment |
| Area under curve (AUC) | Area under the plasma concentration-time curve | Within the first 5 weeks from start of fluzoparib treatment |
| V/F | Volume of distribution | From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment |
| CL/F | Plasma Clearance | From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment |
| 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 |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |