NCT01024062已完成2 期
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Bristol-Myers Squibb0 个研究点目标入组 60 人开始时间: 2002年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with no prior chemotherapy who meet either of the listed below:
- •Patient with stage IIIB or IV disease
- •Patients with recurrent disease following potentially curative surgical resection
- •Patients with previous chemotherapy up to one regimen
排除标准
- •Patients with serious, uncontrolled medical illness
- •Patients with previous therapy with taxanes
研究组 & 干预措施
Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
时间窗: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
时间窗: Each 49 day course of treatment until withdrawal or unacceptable toxicity
次要结局
- Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents](Each 49 day course of treatment until withdrawal or unacceptable toxicity)
研究者
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