NCT00103701已完成1 期
Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2003年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Establishment of MTD and recommended Phase II dose.
研究概览
简要总结
The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
- •Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
- •Men and women, 14 years of age or older.
- •Adequate renal function.
- •Adequate hepatic function.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
排除标准
- •Patients who are eligible and willing to undergo transplantation during the screening period.
- •Women who are pregnant or breastfeeding.
- •A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •Uncontrolled or significant cardiovascular disease.
- •Medications that increase bleeding risk.
- •Medications that change heart rhythms.
- •Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
- •History of significant bleeding disorder or unrelated to CML.
- •Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
研究组 & 干预措施
1
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Establishment of MTD and recommended Phase II dose.
次要结局
- 1) Hematologic Response 2) Cytogenetic Response.
研究者
研究点 (1)
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