Ovarian Cancer Clinical Trial
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
| Verified date | May 2024 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 224 |
| Est. completion date | June 30, 2026 |
| Est. primary completion date | June 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| China | Peking University First Hospital | Beijing | Beijing |
| China | Jilin Cancer Hospital | Changchun | Jilin |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | West China Hospital Sichuan University | Chengdu | Sichuan |
| China | Chongqing University Cancer Hospital | Chongqing | Chongqing |
| China | The First Hospital Affiliated to AMU(Southwest Hospital) | Chongqing | Chongqing |
| China | The Second Hospital of Dalian Medical University | Dalian | Liaoning |
| China | Sun Yat-Sen Memorial Hospital Sun Yat-Sen University | Guangzhou | Guangdong |
| China | The First Affiliate Hospital of Guangzhou Medical University | Guangzhou | Guangzhou |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Anhui Provincial Cancer Hospital | Hefei | Anhui |
| China | The First Bethune Hospital of Jilin University | Jilin | Changchun |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi |
| China | Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College | Nanning | Guangxi |
| China | Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai |
| China | Cancer Hospital of Shantou University Medical College | Shantou | Guangdong |
| China | Liaoning Cancer Hospital&Institute | Shenyang | Liaoning |
| China | Tianjin Central Hospital of Gynecology Obstetrics | Tianjin | Tianjin |
| China | Tianjin Medical University Cancer institute & Hospital | Tianjin | Tianjin |
| China | Hubei Cancer Hospital | Wuhan | Hubei |
| China | Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Yantai Yuhuangding Hospital | Yantai | Shandong |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival | Up to 2 years | ||
| Secondary | Overall survival | up to 3 years | ||
| Secondary | Objective response rate | up to 2 years | ||
| Secondary | Duration of response | up to 2 years |
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