NCT00022451已完成1 期
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 119
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the toxicity profile of this drug in these patients.
Secondary
- Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug.
- Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
研究点 (119)
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