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This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZL-2306(Niraparib) | Experimental | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-2306(Niraparib) | Drug | The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1). | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). | Up to 3 years |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients must be female and at least 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Rutie Yin | West China Second University Hospital | Principal Investigator |
| Xiaohua Wu | Fudan University | Principal Investigator |
| Hong Zheng | Peking University Cancer Hospital & Institute | Principal Investigator |
| Ge Lou | Harbin Medical University | Principal Investigator |
| Lingying Wu | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Hongmin Pan | Sir Run Shaw Hospital, school of medicine, Zhejiang University | Principal Investigator |
| Zhongqiu Lin | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| Cancer Hospital Chinese Academy of Medical Sciences |
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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 |
|---|---|
| C545685 | niraparib |
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Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact method was used to calculate 95% confidence interval. |
| Up to 3 years |
| Progression Free Survival (PFS) | Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1). | Up to 3 years |
| Overall Survival (OS) | Overall Survival was defined as the time from the date of the first dose to the date of death by any cause. | Up to 3 years |
| Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE To evaluate the safety and tolerability of niraparib | An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. | Up to 3 years |
| Beijing |
| Beijing Municipality |
| China |
| Sun Yat-sen Memorial Hospital,Sun Yat-sen University | Guangzhou | Guangdong | China |
| Harbin Medical University | Haerbin | Heilongjiang | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
| West China Second Iniversity Hospital | Chengdu | Sichuan | China |
| Sir Run Shaw Hospital, school of medicine, Zhejiang University | Guangzhou | Zhejiang | China |
| 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 |