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

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pamiparib capsule
Placebo capsule
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Provincial Cancer Hospital
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Beijing Cancer Hospital
  • The First Bethune Hospital of Jilin University
  • Chongqing University Cancer Hospital
  • The First Hospital Affiliated to AMU(Southwest Hospital)
  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
  • Cancer Hospital of Shantou University Medical College
  • Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
  • The First Affiliate Hospital of Guangzhou Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • Jiangxi Maternal and Child Health Hospital
  • Jilin Cancer Hospital
  • The Second Hospital of Dalian Medical University
  • Liaoning Cancer Hospital&Institute
  • Qilu Hospital of Shandong University
  • Yantai Yuhuangding Hospital
  • Obstetrics and Gynecology Hospital of Fudan University
  • West China Hospital Sichuan University
  • Tianjin Central Hospital of Gynecology Obstetrics
  • Tianjin Medical University Cancer institute & Hospital
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment arm

Placebo arm

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival
Objective response rate
Duration of response

Full Information

First Posted
April 26, 2018
Last Updated
August 1, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03519230
Brief Title
Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pamiparib capsule
Other Intervention Name(s)
BGB-290
Intervention Description
60 mg twice daily (BID), orally (per os-PO)
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
60mg BID, PO
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 3 years
Title
Objective response rate
Time Frame
up to 2 years
Title
Duration of response
Time Frame
up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ma, PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Bethune Hospital of Jilin University
City
Jilin
State/Province
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
The First Hospital Affiliated to AMU(Southwest Hospital)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515063
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The First Affiliate Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116044
Country
China
Facility Name
Liaoning Cancer Hospital&Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Central Hospital of Gynecology Obstetrics
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin Medical University Cancer institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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