EUCTR2012-003474-36-ES进行中（未招募）1 期
A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancer
ovartis Farmaceútica, S.A0 个研究点目标入组 105 人开始时间: 2012年10月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC that carries an ALK rearrangement defined as 15% or more positive tumor cells as assessed by the FDA-approved FISH test (Abbott Molecular Inc)
- •2. Age 18 years or older at the time of informed consent.
- •3. Patients must have NSCLC that has progressed during therapy.
- •4. Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
- •5. Patients must have archival tissue, collected either at the time of diagnosis of NSCLC or any time since.
- •6. Patients must have recovered from all toxicities related to prior anticancer therapies to grade ? 2 except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study
- •Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
- •2. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
- •3. History of carcinomatous meningitis.
- •4. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- •5. Clinically significant, uncontrolled heart disease
- •Other protocol defined exclusion criteria may apply
研究者
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