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This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib | Experimental | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate at 24 months (PFS24) | PFS rate at 24 months is defined as the percentage of participants who have not progressed or died within 24 months after niraparib treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method. | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate at 12 months (PFS12) | PFS rate at 12 months after niraparib treatment initiation according to investigator assessment | At 12 months |
| Time to First Subsequent Therapy (TFST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Zheng, M.D. | Contact | 86-010-88196100 | zhhong306@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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Time from the date of initiation of maintenance therapy with niraparib to the date of the first subsequent anticancer therapy or death, whichever occurred first.
| up to 36 months |
| Time to Second Subsequent Therapy (TSST) | Time from the date of initiation of maintenance therapy with niraparib to the date of the second subsequent anticancer therapy or death, whichever occurred first. | up to 48 months |
| Median Progression Free Survival(mPFS) | Time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study | up to 36 months |