NCT00500006终止1 期
A Phase I Dose Escalation of MK0457 in Combination With Dasatinib in Patients With 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
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Pharmacokinetics, Safety, Tolerability
研究概览
简要总结
This study will evaluate MK0457 in combination with Dasatinib 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
- Parallel
- 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
- •Patients must have chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
- •Patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for CML or Ph+ ALL and be evaluable for hematologic response prior to entering the study
- •Patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry
- •Patients with active CNS disease are included and may be treated concurrently with intrathecal therapy as per institutional standards
排除标准
- •Patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. Pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility
- •Patient has unresolved more than or equal to grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry
- •Patient has known hypersensitivity to the components of study drug or its analogs
- •Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
- •Patient has symptomatic ascites, pericardial or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible
- •Patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy
- •Patient has a LVEF <40% by multigated radionucleotide angiography (MUGA) or echocardiography
研究组 & 干预措施
A
Other
Arm A: Drug and comparator
干预措施: MK0457 (Drug)
A
Other
Arm A: Drug and comparator
干预措施: dasatinib (Drug)
B
Other
Arm B: Drug and comparator
干预措施: MK0457 (Drug)
B
Other
Arm B: Drug and comparator
干预措施: dasatinib (Drug)
结局指标
主要结局
Pharmacokinetics, Safety, Tolerability
时间窗: 28 Days
次要结局
- Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability(28 Days)
研究者
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