NCT00080509终止2 期
A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
Bristol-Myers Squibb0 个研究点目标入组 85 人开始时间: 2003年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 主要终点
- NSCLC
研究概览
简要总结
The purpose of this study is to determine whether a potential drug known as KOS-862 or "Epothilone D" has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.
详细描述
To determine the antitumor activity, based on the confirmed objective response rate, of KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following initial chemotherapy for advanced or metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •At least 18 years of age
- •Measurable disease
- •One previous treatment of a platinum based drug such as cisplatin or carboplatin
- •At least 3 weeks since last surgery/radiation/chemotherapy
排除标准
- •Brain metastases
- •Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing
结局指标
主要结局
NSCLC
次要结局
未报告次要终点
研究者
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