Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

August 1, 2023 updated by: BeiGene

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Cancer Hospital
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100032
        • Peking Union Medical College Hospital
    • Changchun
      • Jilin, Changchun, China, 130021
        • The First Bethune Hospital of Jilin University
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing University Cancer Hospital
      • Chongqing, Chongqing, China, 400038
        • The First Hospital Affiliated to AMU(Southwest Hospital)
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen University
      • Shantou, Guangdong, China, 515063
        • Cancer Hospital of Shantou University Medical College
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510120
        • The First Affiliate Hospital of Guangzhou Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430030
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Maternal and Child Health Hospital
    • Jilin
      • Changchun, Jilin, China, 132000
        • Jilin Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116044
        • The Second Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital&Institute
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Obstetrics and Gynecology Hospital of Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Tianjin Central Hospital of Gynecology obstetrics
      • Tianjin, Tianjin, China, 300070
        • Tianjin Medical University Cancer Institute & Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  2. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
  3. 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
  4. Ability to be randomized ≤8 weeks after last dose of platinum

Key Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  2. Progressive disease (PD) as per CA-125 criteria before randomization
  3. Diagnosis of myelodysplastic syndrome (MDS)
  4. Known history of intolerance to the excipients of the Pamiparib capsule

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Placebo capsule
60mg BID, PO
Experimental: Treatment arm
Drug: Pamiparib capsule
60 mg twice daily (BID), orally (per os-PO)
Other Names:
  • BGB-290

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 3 years
up to 3 years
Objective response rate
Time Frame: up to 2 years
up to 2 years
Duration of response
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Investigators

  • Principal Investigator: Ding Ma, PhD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-290-302
  • ChiCTR1800014643 (Registry Identifier: Chinese Clinical Trial Registry)
  • CTR20171666 (Registry Identifier: Center for drug evaluation, CFDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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