NCT00522145已完成2 期
A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 10
- 主要终点
- Determine the best confirmed response rate
研究概览
简要总结
The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.
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
- •Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
- •Subjects must have:
- •documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
- •a documented T790M EGFR mutation
- •Measurable disease defined according to RECIST
- •ECOG performance status of 0 or
- •Sexually active subjects must use an accepted method of contraception during the course of the study.
- •Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
排除标准
- •Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
- •Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
- •Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
- •Receiving anticoagulation therapy with warfarin.
- •Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
- •Corrected QT interval (QTc) of >0.45 seconds.
- •Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
- •Requires steroid or anticonvulsant therapy for the treatment of brain metastases.
研究组 & 干预措施
Group 1
Experimental
干预措施: XL647 (Drug)
结局指标
主要结局
Determine the best confirmed response rate
时间窗: Inclusion until disease progression
次要结局
- Progression-free survival, duration of response, and overall survival(Incusion until disease progression)
- Safety and tolerability of XL647 administered daily(First treatment until 30 day post last treatment)
- Further characterize the pharmacokinetic (PK) parameters(Every 8 weeks after Day 57 until disease progression)
研究者
研究点 (10)
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