NCT01797874已完成2 期
Phase II Study of Pazopanib Maintenance for SCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed SCLC
- •no disease progression after 4 cycles of etoposide/platinum 1st-line therapy
- •history of 4 cycles of etoposide/platinum 1st-line therapy
- •between 21 days and 42 days since C4D1 of etoposide/platinum
- •no symptomatic brain meta
排除标准
- •poor hepatic, renal function
研究组 & 干预措施
Pazopanib
Experimental
pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC
干预措施: Pazopanib (Drug)
placebo
Placebo Comparator
placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12 months
次要结局
未报告次要终点
研究者
Myung-Ju Ahn
Professor
Samsung Medical Center
研究点 (1)
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