NCT00264160已完成2 期
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cytogenetic response within 12 months
研究概览
简要总结
This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
- •Males or females ≥ 18 years of age
排除标准
- •Impaired cardiac function
- •Acute or chronic liver or renal disease
- •Use of therapeutic coumadin
- •Central nervous system (CNS) infiltration
- •Additional protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
AMN107
Experimental
干预措施: AMN107 (Drug)
结局指标
主要结局
Cytogenetic response within 12 months
时间窗: Every 6 months for 12 months
次要结局
- To determine the rate of hematologic response at 12 months(Every Visit for 12 months)
- To determine the rate of molecular response at 12 months(Every 3 months for 12 months)
- To evaluate the time to cytogenetic and molecular response(At 12 months)
研究者
研究点 (1)
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