NCT03519230进行中（未招募）3 期
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
BeiGene52 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
- 试验地点
- 52
- 主要终点
- Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treatment arm
Experimental
干预措施: Pamiparib capsule (Drug)
Placebo arm
Placebo Comparator
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment
时间窗: up to 8 years
次要结局
- Overall survival(up to 9 years)
- Objective response rate by investigator assessment(up to 2 years)
- Number of participants with treatment-emergent adverse events (TEAEs)(up to 9 years)
- Duration of response by investigator assessment(up to 2 years)
- PFS by investigator assessment(up to 8 years)
- Time to response by investigator assessment(up to 8 years)
研究者
研究点 (52)
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