- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519230
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230088
- Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
-
-
Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100034
- Peking University First Hospital
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Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital
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-
Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400030
- Chongqing Cancer Hospital
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Chongqing, Chongqing Municipality, China, 400038
- Southwest Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, China, 510000
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
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Shantou, Guangdong, China, 515031
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, China, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Harbin Medical University Cancer Hospital
-
-
Henan
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Zhengzhou, Henan, China, 450000
- Henan Cancer Hospital
-
-
Hubei
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Wuhan, Hubei, China, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430030
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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-
Hunan
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Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
-
-
Jiangxi
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Nanchang, Jiangxi, China, 330006
- Jiangxi Maternal and Child Health Hospital
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-
Jilin
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Changchun, Jilin, China, 130021
- The First hospital of Jilin University
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Changchun, Jilin, China, 130021
- Jilin Cancer Hospital
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-
Liaoning
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Dalian, Liaoning, China, 116023
- The Second Hospital of Dalian Medical University
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Shenyang, Liaoning, China, 110042
- Liaoning Cancer Hospital and Institute
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Shandong
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Jinan, Shandong, China, 250000
- Qilu Hospital of Shandong University
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Yantai, Shandong, China, 264000
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200011
- Obstetrics and Gynecology Hospital of Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610101
- West China Second University Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, China, 300052
- Tianjin Central Hospital of Gynecology Obstetrics
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo arm
|
60mg BID, PO
|
|
Experimental: Treatment arm
|
60 mg twice daily (BID), orally (per os-PO)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
Time Frame: up to 8 years
|
up to 8 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: up to 9 years
|
up to 9 years
|
|
Objective response rate by investigator assessment
Time Frame: up to 2 years
|
up to 2 years
|
|
Duration of response by investigator assessment
Time Frame: up to 2 years
|
up to 2 years
|
|
PFS by investigator assessment
Time Frame: up to 8 years
|
up to 8 years
|
|
Time to response by investigator assessment
Time Frame: up to 8 years
|
up to 8 years
|
|
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: up to 9 years
|
up to 9 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, BeiGene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- Poly(ADP-ribose) Polymerase Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- pamiparib
Other Study ID Numbers
- BGB-290-302
- ChiCTR1800014643 (Registry Identifier: Chinese Clinical Trial Registry)
- CTR20171666 (Registry Identifier: ChinaDrugTrials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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