NCT00276276已完成3 期
An Open-Label, Multicentre, Randomised, Phase III Comparator Study of Active Symptom Control Alone or in Combination With Oral Topotecan in Patients With Relapsed Resistant SCLC
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 18
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed small cell lung cancer benefits them. The study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received one prior chemotherapy regimen only.
- •Documented partial or complete response to first-line therapy.
- •Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy.
- •Not considered suitable for further intravenous chemotherapy.
- •Considered to have adequate bone marrow reserve.
- •Performance Status of 0, 1 or 2.
排除标准
- •Pregnant or lactating.
- •Received more than one prior regimen of chemotherapy.
- •Uncontrolled vomiting.
- •Brain metastases.
- •Active uncontrolled infection.
- •Received previous treatment with HYCAMTIN.
- •Received an investigational product within 30 days.
结局指标
主要结局
Overall survival
次要结局
- Time to response, response rate, time to disease progression
研究者
研究点 (18)
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