NCT02435108已完成2 期
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
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
- 2
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of fully informed consent prior to any study specific procedures.
- •Patients must be ≥20 years of age.
- •Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
- •c-MET positive gastric cancer
- •ECOG PS 0-2
- •At least one measurable disease
- •Proper organ function
排除标准
- •severe co-morbid illness and/or active infections
- •pregnant or lactating women
- •History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
- •active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
- •known history of hypersensitivity to study drugs
研究组 & 干预措施
crizotinib arm
Experimental
crizotinib medication
干预措施: crizotinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: expected average of 24 weeks
次要结局
- overall response rate(up too 100 weeks)
- overall survival(up too 100 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up too 100 weeks)
研究者
Jeeyun Lee
MD, PhD, Division of hematology-oncology, Department of medicine,
Samsung Medical Center
研究点 (1)
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