NCT00129168已完成1 期
An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia
Kanisa Pharmaceuticals0 个研究点目标入组 100 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.
详细描述
Purpose:
Phase I:
To Evaluate the safety of different doses of zosuquidar.
Phase II:
This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed acute myeloid leukemia
- •Ages 55-75 years
排除标准
- •Acute promyelocytic leukemia (FAB M3)
- •Patients must not have received prior chemotherapy for AML.
- •Prior exposure to anthracycline
- •Use of any investigational agent within 4 weeks prior to enrollment into the study
- •For Phase II:
- •Patients must be P-glycoprotein positive
研究者
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