NCT00660504已完成3 期
Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
Sumitomo Pharma (Suzhou) Co., Ltd.0 个研究点目标入组 300 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Overall Survival
研究概览
简要总结
This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
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
- 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/cytologically proven small cell lung cancer
- •Extensive disease
- •No prior chemotherapy regimen
- •Age 18 years or older
- •ECOG performance status of 0-1
排除标准
- •Brain metastasis requiring treatment
- •Treatment (Surgical or radiotherapy)of primary tumor
- •Interstitial pneumonia or pulmonary fibrosis
- •Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
研究组 & 干预措施
1
Experimental
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
干预措施: Amrubicin Hydrochloride (Drug)
2
Active Comparator
Etoposide-Cisplatin combined chemotherapy
干预措施: Etoposide-Cisplatin combined chemotherapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1.5 years after last subject enrolled
次要结局
- Objective Response Rate(participants were followed for the duration of the study, an average of 12 weeks)
- Progression-Free Survival(1.5 years after last subject enrolled)
研究者
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