JPRN-UMIN000028075已完成1 期
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma - A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
St. Marianna University School of Medicine Hospital National Center for Child Health and Development Nagoya Medical Center Kyushu University Hospital0 个研究点目标入组 23 人开始时间: 2017年7月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
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
- 1years-old 至 22years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •[Phase 1/2 parts] 1) Patients with CNS (central nervous system)disease. 2) Primary cutaneous ALCL. 3) Pregnant or brest-feeding women. 4) Patients of reproductive potential who have not agreed to use an effective contraception method. 5) Patients receiving the following concomitant medications 5-1) Therapeutic corticosteroids for lymphoma 5-2) investigational instruments and clinical trial products. 5-3) Anticancer agents 5-4) narrow therapeutic indice CYP3A4 substrates 5-5) Strong CYP3A4 inhibitors 5-6) Strong CYP3A4 inducers 6) Patients with interstitial fibrosis or interstitial lung disease or with a known history of those. 7) Patients with myocardial infarction or cerebrovascular disorder or with a known history of those. 8) Patients having an uncontrolled infectious disease. 9) Those who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. 10) Patient who can not take capsule formulation or liquid formulation. However, administration of the liquid preparation via the feeding tube is permitted.
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