NCT01784107Unknown1 期
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- MTD (maximal tolerated dose)
研究概览
简要总结
Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.
Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •histologically or cytologically confirmed extensive disease of Small cell lung cancer
- •no prior chemotherapy or radiotherapy for lung
- •measurable lesion for RECIST
- •over 18 years
- •ECOG 0~2
- •expected life span more than 3 months
排除标准
- •acute or active infection
- •uncontrolled cerebral nerve symptoms or metastasis
- •significant myocardial infarction or cardiac disease within 12 months
研究组 & 干预措施
Belotecan and Ifosfamide
Experimental
干预措施: Belotecan and Ifosfamide (Drug)
结局指标
主要结局
MTD (maximal tolerated dose)
时间窗: one year
次要结局
- DLT(dose-limiting toxicity)(one year)
研究者
Eun Kyung Cho
Professor
Gachon University Gil Medical Center
研究点 (1)
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