JPRN-UMIN000026669已完成未知
A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation - A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
The Japan-Multinational Trial Organization0 个研究点目标入组 25 人开始时间: 2017年3月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
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
- •1) Patients with a history of severe allergy or hypersensitivity to the ingredients of the drugs used 2) Cases with pleurodesis 3) Case of treatment history of Osimeltinib and other third generation EGFR-TKI 4) Patients treated with immune checkpoint inhibitors 5) Cases with major surgery within 4 weeks 6) Patients who are concomitantly taking drugs with strong inducing action on cytochrome P450 (CYP) 3A4 or supplements of Chinese traditional herbs (or patients who can not be discontinued at least 1 week before the first dose) 7) Cases with complications of malignancy and / or other active malignant tumors requiring treatment within one year prior to the first dose 8) Cases with serious complications 9) Examples of symptomatic brain metastasis and spinal cord pressure exclusion (cases that can be controlled by treatment can be registered) 10) Cases with obvious interstitial pneumonia or pulmonary fibrosis in chest CT or cases with a history of interstitial pneumonia 11) Patients with a history of gastrointestinal resection such as refractory nausea and vomiting, chronic gastrointestinal disorder, inability to swallow or absorption possibly significantly affecting absorption of osimertinib 12) Case in which QTc value is 470 msec or more in electrocardiogram examination at screening 13) Case with corneal ulcer 14) Cases with difficult ingestion 15) Pregnant women or lactating women 16) Other cases, cases in which doctor in charge judged inappropriate as the subject of this study (examples where dementia patients or psychiatric patients are difficult to perform the test)
研究者
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