A Phase I Study Of CEP-701 In Patients With Refractory Neuroblastoma (IND # 67,722)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 12
- 主要终点
- To determine dose limiting toxicities (DLTs) of CEP-701 given on this schedule
研究概览
简要总结
RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of CEP-701 in pediatric patients with recurrent or refractory high-risk neuroblastoma.
- Determine the dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetic behavior of this drug in these patients.
Secondary
- Determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with this drug.
- Correlate the degree of TrkB tyrosine kinase inhibition activity in these patients with dose level, pharmacokinetics, and antitumor activity data of this drug.
- Determine the antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 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
研究组 & 干预措施
Single Group
干预措施: lestaurtinib (Drug)
结局指标
主要结局
To determine dose limiting toxicities (DLTs) of CEP-701 given on this schedule
时间窗: Within first 28 days of therapy.
To characterize the pharmacokinetic (PK) behavior of CEP-701 in children with residual or refractory high-risk neuroblastoma.
时间窗: Days 1,5 and 26 of first course only.
Participation in PK studies is voluntary and not a requirement for study entry.
To determine the maximum tolerated dose (MTD) of CEP-701 given on a twice daily chronic administration schedule (two days on , two days off) to children with high risk relapsed or residual neuroblastoma.
时间窗: Within 28 days of treatment at each dose level.
次要结局
- To determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with CEP-701, and correlate these findings with dose level, pharmacokinetic and anti-tumor activity data.(Days 1,5 and 26 of first course only.)
- To define the antitumor activity of CEP-701, within the confines of a Phase I study.(Evaluation at end of courses 1, 2, 4 and then every 4 courses until patient goes off therapy.)