JPRN-UMIN000031623已完成未知
Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer - Phase II Study of Crizotinib in MET alteration+ NSCLC
ational Kyushu Cancer Center0 个研究点目标入组 29 人开始时间: 2018年3月20日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients presenting with any of the following will not be included in the trial: 1) Current treatment on another therapeutic clinical trial. 2) Characterized ALK or ROS1-positive rearrangement 3) Prior therapy specifically directed against MET 4) Any prior treatment (chemotherapy, radiation or surgery) within 2 weeks prior to study entry. 5) Any > Grade 1 acute toxicity (except alopecia). 6) Symptomatic brain metastases. 7) Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease. 8) Known interstitial fibrosis or interstitial lung disease. 9) Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. 10) Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec. 11) Pregnancy or breastfeeding. 12) Use of drugs or foods after study enrollment that are known potent CYP3A4 inhibitors. 13) Use of drugs after study enrollment that are known potent CYP3A4 inducers. 14) Use of drugs after study enrollment that are CYP3A4 substrates with narrow therapeutic indices. 15) Any other anti-cancer drugs are prohibited. 16) Evidence of active malignancy within the last 3 years. 17) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study. 18)Patients whom investigator judges to be inappropriate as a participant.
研究者
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