NCT01167244已完成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 Squibb1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年8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
- 11
- 试验地点
- 1
- 主要终点
- To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
研究概览
简要总结
The purpose of this study is to observe an improvement in overall response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy. Subjects must have:
- •Pathologically confirmed NSCLC
- •Previously received treatment with single agent Gefitinib or Erlotinib and completed treatment at least 2 weeks prior to study entry
- •Any one of the following:
- •A tumor that harbors an EGFR mutation
- •Objective clinical benefit from treatment with Gefitinib or Erlotinib as defined by either documented and confirmed partial or complete response (RECIST or WHO), or significant and durable (≥ 6 months) clinical benefit (stable disease as defined by RECIST or WHO) Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease after having a confirmed partial or complete response or evidence of ≥ 6 months of SD within 3 months of study enrollment
排除标准
- •Symptomatic brain metastasis
- •History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months)
- •History of hemoptysis greater than 10 mL/day within last 30 days
- •Uncontrolled or significant cardiovascular disease
- •History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis
- •Inability to swallow tablets, untreated malabsorption or GI surgery that results in inability to absorb protocol therapy
- •Women unwilling to avoid pregnancy or use adequate contraception
- •History of allergy or adverse drug reaction to gefitinib or erlotinib
研究组 & 干预措施
BMS-690514
Experimental
干预措施: BMS-690514 (Drug)
结局指标
主要结局
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
时间窗: Tumor assessments every 8 weeks from Day 1 by CT or MRI
次要结局
- To estimate disease control rate and progression free survival in all treated subjects(Tumor assessment every 8 weeks from Day 1 until disease progression)
- To evaluate safety and tolerability of BMS-690514 in all treated subjects(Average about 10 months)
研究者
研究点 (1)
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