NCT00324077撤回1 期
A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Bristol-Myers Squibb3 个研究点 分布在 1 个国家开始时间: 2006年8月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
研究概览
简要总结
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females, 18 or older
- •chronic phase Ph+ or BCR-ABL positive CML
- •current complete hematologic response to imatinib
- •lack of major molecular response
- •on imatinib for at least one year
- •on the same imatinib dose for at least 6 months
- •adequate hepatic and renal function
排除标准
- •History of accelerated or blast phase CML
- •Serious uncontrolled medical disorder or active infection
- •Significant cardiovascular disease or bleeding disorder
- •Concurrent use of medications at risk of causing Torsades de Pointe
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
次要结局
- evaluate progressive free survival and overall survival
- identify dose limiting toxicities
- assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
- characterize mutations in the BCR-ABL gene
- characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
- measure major molecular response rate
- measure the major cytogenetic response rate
研究者
研究点 (3)
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