NCT00985868已完成1 期
A CCLG/Cancer Research UK Phase I Trial of AT9283 (a Selective Inhibitor of Aurora Kinases) Given for 72 Hours Every 21 Days Via Intravenous Infusion in Children and Adolescents With Relapsed and Refractory Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Dose-limiting toxicities
研究概览
简要总结
RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children and adolescents with relapsed and refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of Aurora kinase inhibitor AT9283 by characterizing the dose-limiting toxicities in children and adolescents with relapsed and refractory solid tumors.
- To determine the maximum-tolerated dose of this regimen in these patients.
Secondary
- To determine the pharmacokinetic parameters of this regimen in these patients.
- To demonstrate the pharmacodynamic (PD) activity of this regimen in these patients by studying its effects in surrogate tissue.
- To assess preliminary evidence of activity of this regimen by using appropriate objective tumor measurements 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
- 2 Years 至 18 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
结局指标
主要结局
Dose-limiting toxicities
Maximum-tolerated dose
次要结局
- The magnitude and duration of biomarkers (M30 and M65 ELISA) change after AT9283 administration
- Pharmacokinetic parameters and the correlation between them and toxicity and/or efficacy
- Objective tumor response according to RECIST criteria
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
AT9283 in Treating Young Patients With Relapsed or Refractory Acute LeukemiaLeukemiaNCT01431664Cancer Research UK7
已完成
1 期
Aurora Kinase Inhibitor AT9283 in Treating Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin's LymphomaNon-Hodgkins LymphomaUnspecified Adult Solid Tumor, Protocol SpecificNCT00443976NCIC Clinical Trials Group35
进行中（未招募）
1 期
AT9283 in children and adolescents with acute leukaemiaEUCTR2009-016952-36-GBCancer Research UK7
已完成
1 期
AT9283 in children and adolescents with acute leukaemiaCancerISRCTN97388141Cancer Research UK7
已完成
1 期
ABT-888 in Patients With Refractory Solid Tumors or Hematologic CancerUnspecified Adult Solid Tumor, Protocol SpecificLymphomaLeukemiaNCT00387608National Institutes of Health Clinical Center (CC)23