Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
3 other identifiers
interventional
224
1 country
28
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 ovarian-cancer
Started May 2018
Longer than P75 for phase_3 ovarian-cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedStudy Start
First participant enrolled
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedMarch 16, 2026
March 1, 2026
7.6 years
April 26, 2018
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
up to 8 years
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Treatment arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (28)
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011, China
West China Second University Hospital
Chengdu, Sichuan, 610101, China
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2018
First Posted
May 8, 2018
Study Start
May 14, 2018
Primary Completion
December 1, 2025
Study Completion (Estimated)
January 30, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.