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

Phase 3

Active, not recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Placebo capsule; Drug: Pamiparib 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-08
• Study Start: 2018-05-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 224

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo capsule	-
Treatment arm	Pamiparib capsule	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years
Objective response rate	up to 2 years
Duration of response	up to 2 years

Trial Locations

Locations (29)

Anhui Provincial Cancer Hospital; 🇨🇳 Hefei, Anhui, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Jiangxi Maternal and Child Health Hospital; 🇨🇳 Nanchang, Jiangxi, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

The Second Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China

Tianjin Central Hospital of Gynecology Obstetrics; 🇨🇳 Tianjin, Tianjin, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliate Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangzhou, China

West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Liaoning Cancer Hospital&Institute; 🇨🇳 Shenyang, Liaoning, China

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Cancer Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Tianjin Medical University Cancer institute & Hospital; 🇨🇳 Tianjin, Tianjin, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

The First Hospital Affiliated to AMU(Southwest Hospital); 🇨🇳 Chongqing, Chongqing, China

Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College; 🇨🇳 Nanning, Guangxi, China

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital; 🇨🇳 Hefei, Anhui, China

The First Bethune Hospital of Jilin University; 🇨🇳 Jilin, Changchun, China

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China