NCT00065182已完成2 期
WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 86
- 主要终点
- Median Time of Overall Survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Median Time of Overall Survival
时间窗: Up to one year from Day -1 (randomization)
Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
次要结局
- Number of Participants With One-year Survival(Up to one year from Day -1 (randomization))
- Median Time to Progression(Up to one year from Day -1 (randomization))
- Response Rate(Up to one year from Day -1 (randomization))
- Response Duration(Up to one year from Day -1 (randomization))
- Time to Response-assessed Every 8 Weeks(Every 8 Weeks post randomization)
- Assessment of Quality of Life-assessed Every 4 Weeks(Every 4 Weeks post randomization)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 16 months)
- Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities(Up to 16 months)
- Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities(Up to 16 months)
- Number of Participants With Clinically Significant Abnormal Vital Signs Data(Up to 16 months)
研究者
研究点 (86)
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