JPRN-UMIN000022553已完成2 期
A phase II trial on efficacy and safety of osimertinib in elderly EGFR T790M-positive non-small-cell lung cancer patients who progressed during prior EGFR-TKI treatment or had recurrence - SPIRAL Study
Clinical Research Support Center Kyushu0 个研究点目标入组 35 人开始时间: 2016年7月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- 75years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients who have treatment history of osimertinib and other 3rd generation EGFR-TKI. 2.Patients with pulmonary disorders such as Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis and drug-induced pneumonia. 3.Patients with infectious disorder need for intravenous injection of antibacterial drug and antimycotics. 4.Patients unable to swallow oral medications. 5.Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4. 6.Patients currently receiving checkpoint inhibitor or with treatment history. 7.Patients with any of the following cardiac criteria: 1)Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec 2)Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) 3)Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval 8.Patients who are pregnant, nursing or possibly pregnant. 9.Patients with brain metastasis accompanying symptoms. 10.Patients with active double cancer. 11.Patients with uncontrollable diabetes mellitus. 12.Patients who have complications to be clinical problem (Such as uncontrollable cardiac disease, severe cardiac arrhythmia to need medical treatment, sustained serious diarrhoea)
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