NCT01562015已完成2 期
A Single Arm, Phase 2 Study of Ganetespib in Subjects With Advanced Non-Small-Cell Lung Cancer With Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)
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
- 12
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.
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
- •Males or females aged 18 years or older
- •Pathological confirmation of advanced NSCLC
- •Evidence of a translocation or an inversion event involving the ALK gene locus
- •ECOG Performance Status 0 or 1
排除标准
- •Prior therapy with ALK-targeted agents
- •Prior treatment with Hsp90 inhibitor
- •Known EGFR activating mutation
- •Presence of active or untreated central nervous system (CNS) metastases
研究组 & 干预措施
Ganetespib
Experimental
Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
干预措施: Ganetespib (Drug)
结局指标
主要结局
Objective response rate
时间窗: 1 year
次要结局
- Duration of Response(1 year)
- Disease Control Rate(6 weeks and 12 weeks)
- Adverse events(1 year)
- Progression Free Survival(From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years)
- Overall Survival(1 year)
研究者
研究点 (1)
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