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| Name | Class |
|---|---|
| Zai Lab (Shanghai) Co., Ltd. | INDUSTRY |
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This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).
This study will investigate the efficacy and safety of niraparib maintenance re-treatment in patients with PSR non-mucinous EOC, who have previously received maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy). Patients will be enrolled, given niraparib and anlotinib maintenance treatment until disease progression or untolerated toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib combined with Anlotinib | Experimental | Participants received Niraparib 200mg or 300mg QD PO continually and Anlotinib 10mg QD PO on Days 1-14 (21 days/cycle) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib 200 or 300mg* QD PO continually; *The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight <77 kg or platelets count <150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL. For patients who had experienced grade 4 adverse events from previous use of PARPi, niraparib staring dose was 200 mg QD. Anlotinib 10mg QD PO from Day 1 to 14 of every 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is assessed as the time from niraparib treatment initiation to the earlier date of assessment of progression, as assessed by RECIST v1.1 criteria based on Investigator assessment, or death by any cause in the absence of progression | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate at 6 months | PFS rate at 6 months is defined as the proportion of participants who have not progressed or died within 6 months after niraparib treatment initiation. Progression will be assessed by RECIST v1.1 criteria per investigator assessment) | 6 months |
| Time to First Subsequent Therapy (TFST) |
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Inclusion Criteria:
Exclusion Criteria:
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TFST is defined as the date of initiation of niraparib treatment in the current study to the start date of the first subsequent anticancer therapy. |
| The date of initiation of niraparib treatment in the current study to the start date of the first subsequent anticancer therapy assessed up to 15 months. |
| Overall Survival (OS) | OS is defined as the date of initiation of niraparib treatment to the date of death by any cause. | From the time of enrollment to date of death by any cause assessed up to 36 months. |
| Frequency and severity of adverse effects as defined by CTCAE version 5.0 | Number of patients with any non-serious adverse event (non-SAE) or any SAE to evaluate the safety and tolerability of niraparib combined with anlotinib. | From the time of enrollment to date of 30 days after the last study drug administration. |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
|---|---|
| C545685 | niraparib |
| C000625192 | anlotinib |
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