Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Drug: Placebo capsule
- Registration Number
- NCT03519230
- Lead Sponsor
- BeiGene
- Brief Summary
To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 224
- Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
- Completion of β₯2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
- Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Ability to be randomized β€8 weeks after last dose of platinum
Key
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
- Progressive disease (PD) as per CA-125 criteria before randomization
- Diagnosis of myelodysplastic syndrome (MDS)
- Known history of intolerance to the excipients of the Pamiparib capsule
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm Pamiparib capsule - Placebo arm Placebo capsule -
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment up to 8 years
- Secondary Outcome Measures
Name Time Method Overall survival up to 9 years Objective response rate by investigator assessment up to 2 years Duration of response by investigator assessment up to 2 years PFS by investigator assessment up to 8 years Time to response by investigator assessment up to 8 years Number of participants with treatment-emergent adverse events (TEAEs) up to 9 years
Trial Locations
- Locations (28)
The First Hospital of Jilin University
π¨π³Changchun, Jilin, China
Southwest Hospital
π¨π³Chongqing, Chongqing, China
Chongqing Cancer Hospital
π¨π³Chongqing, Chongqing, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
π¨π³Nanning, Guangxi, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Liaoning Cancer Hospital and Institute
π¨π³Shenyang, Liaoning, China
West China Second University Hospital
π¨π³Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
π¨π³Tianjin, Tianjin, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
π¨π³Hefei, Anhui, China
Peking University First Hospital
π¨π³Beijing, Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, Beijing, China
Cancer Hospital of Shantou University Medical College
π¨π³Shantou, Guangdong, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, Heilongjiang, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Hubei Cancer Hospital
π¨π³Wuhan, Hubei, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital
π¨π³Nanchang, Jiangxi, China
Jilin Cancer Hospital
π¨π³Changchun, Jilin, China
The Second Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
Qilu Hospital of Shandong University
π¨π³Jinan, Shandong, China
Yantai Yuhuangding Hospital
π¨π³Yantai, Shandong, China
Obstetrics and Gynecology Hospital of Fudan University
π¨π³Shanghai, Shanghai, China
Tianjin Central Hospital of Gynecology Obstetrics
π¨π³Tianjin, Tianjin, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Zhejiang, China