NCT00337454已完成1 期
A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年7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
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
研究概览
简要总结
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Philadelphia chromosome positive or bcr-abl gene positive
- •Chronic Myelogenous Leukemia (CML)
- •Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
- •Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
- •Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
- •Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- •Men and women, ages 20 - 75
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
排除标准
- •Subjects who are eligible and willing to undergo transplantation at pre-study
- •Women who are pregnant or breastfeeding
- •Uncontrolled or significant cardiovascular disease
- •History of significant bleeding disorder unrelated to CML or ALL
- •Adequate hepatic function
- •Adequate renal function
- •Medication that increase bleeding risk
- •Medication that change heart rhythms
- •Subjects who are compulsorily detained for legal reasons or 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
A1
Experimental
干预措施: Dasatinib (Drug)
A2
Experimental
干预措施: Dasatinib (Drug)
A3
Experimental
干预措施: Dasatinib (Drug)
B1
Experimental
干预措施: Dasatinib (Drug)
B2
Experimental
干预措施: Dasatinib (Drug)
B3
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
次要结局
- Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
- response
研究者
研究点 (1)
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进行中（未招募）
不适用
A Phase II Study to Determine the Activity of BMS-354825 in Subjects with ChronicPhase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who HaveDisease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who areIntolerant of ImatinibRevised Protocol 01 version 4.0, incorporating Amendment 02 and Administrative Letter dated 01-Mar-2005, and Amendment 01 version 2.0 dated 28-Apr-2005EUCTR2004-002601-69-DEBristol Myers Squibb International Corporation250