NCT00405054终止2 期
A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 主要终点
- efficacy
研究概览
简要总结
This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.
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
- •This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia)
- •Patients must have adequate organ function
- •Patients must have documented T315I mutation
排除标准
- •Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy
- •Patients with uncontrolled congestive heart failure
- •Patients with active or uncontrolled infection or active Hepatitis B or C
- •Patients with known HIV positivity or AIDS related illness
- •Patients with currently active second malignancy, other than non-melanoma skin cancer.
研究组 & 干预措施
1
Other
continuous infusion every 14 days
干预措施: MK0457 (Drug)
结局指标
主要结局
efficacy
时间窗: 24 Months
次要结局
未报告次要终点
研究者
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