JPRN-jRCT2080221778未知1 期
A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients with ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated with Chemotherapy and Crizotinib
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 121
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Locally advanced or metastatic non-small cell lung cancer (NSCLC)
- •- ALK-rearrangement confirmed by FDA approved test
- •- Phase I: NSCLC that has failed crizotinib treatment
- •- Phase II: NSCLC that has failed crizotinib and at least one line of platinum-based chemotherapy treatment
- •- Measurable disease as defined by RECIST v1.1
- •- ECOG performance status - Adequate hematologic, hepatic and renal function
排除标准
- •- Prior therapy with an ALK inhibitor other than crizotinib
- •- Brain metastases that are symptomatic and/or requiring treatment
- •- History of serious cardiac dysfunction
- •- History of or current active infection with hepatitis B, hepatitis C or HIV
- •- Clinically significant gastrointestinal abnormality that would affect absorption of the drug
- •- Pregnant or lactating women
研究者
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