EUCTR2012-002074-31-ES进行中（未招募）1 期
A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK) - Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALK
ovartis Farmacéutica, S.A.0 个研究点目标入组 80 人开始时间: 2013年6月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •- Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
- •- Age ? 12 months and ? 17years
- •- The tumor must carry a genetic alteration of ALK
- •- Patients must have evaluable or measurable disease
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
- •- Clinically significant, uncontrolled heart disease
- •- Inadequate end organ function as defined by specified laboratory values
- •- Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
- •- Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study.
- •Other protocol-defined exclusion criteria may apply
研究者
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