jRCT2080221239未知2 期
Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
Bristol-Myers K.K.0 个研究点目标入组 56 人开始时间: 待定
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 56
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- The study design is a single arm open label study to evaluate the efficacy and safety of BMS-690514 in NSCLC subjects.
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects must have recurrent, metastatic or progressive NSCLC
- •Pathologically confirmed NSCLC
- •Previously received treatment with single agent Gefitinib or Erlotinib
- •Any one of the following:
- •A tumor that harbors an EGFR mutation
- •Objective clinical benefit from treatment with Gefitinib or Erlotinib
- •Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease within 3 months of study enrollment
排除标准
- •Symptomatic brain metastasis
- •Adequate organ function and performance status
结局指标
主要结局
-
- To estimate objective response rate of BMS-690514 in NSCLC subjects
次要结局
- progression free survival
- safety and tolerability
研究者
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