CTRI/2016/09/007291招募中4 期
A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluatethe effectiveness and tolerability of ceritinib in Indian patients with ALK positive metastatic non-smallcell lung cancer who have progressed or are intolerant to crizotinib. - CONNECT-CLDK378AIN01
ovartis Healthcare Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Willing to provide signed ICF indicating that he/she understand the purpose and are
- •willing to participate in the study.
- •2. Patient is 18 years of age or older at the time of informed consent.
- •3. Patient with ALK-positive metastatic NSCLC who has progressed on or is intolerant
- •to crizotinib.
- •4. Patient being newly initiated on ceritinib treatment based on independent clinical
- •judgment of treating physician as per locally approved prescribing information.
排除标准
- •1. Patient who is not eligible to receive ceritinib as per the locally approved prescribing
- •information.
- •2. Patient with known hypersensitivity to any of the excipients of ceritinib
- •(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, and
- •magnesium stearate).
- •3. Patient with any contraindication as per the locally approved prescribing information.
研究者
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