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 ≥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 ≤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 Duration of response by investigator assessment up to 2 years Time to response by investigator assessment up to 8 years Number of participants with treatment-emergent adverse events (TEAEs) up to 9 years Overall survival up to 9 years Objective response rate by investigator assessment up to 2 years PFS by investigator assessment up to 8 years
Trial Locations
- Locations (28)
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Southwest Hospital
🇨🇳Chongqing, Chongqing, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China
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