NCT00349518撤回2 期
A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
Bristol-Myers Squibb20 个研究点 分布在 6 个国家开始时间: 2006年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 20
- 主要终点
- Incidence and severity of drug-related adverse events.
研究概览
简要总结
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.
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
- •CP or AD CML or Ph+ ALL
- •Intolerant of resistant to imatinib
- •ECOG PS 0-2 (CP CML)
- •ECOG PS 0-3 (AD CML and Ph+ ALL)
- •Adequate hepatic and renal function
排除标准
- •Pregnant or breastfeeding females
- •History of significant cardiac disease
- •History of significant bleeding disorder (not CML)
结局指标
主要结局
Incidence and severity of drug-related adverse events.
次要结局
- Chronic Phase CML: Cytogenetic and Hematologic Response
- Time to and duration of Cytogenetic and Hematologic Response
- Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
研究者
研究点 (20)
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