NCT00904787已完成1 期
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events
研究概览
简要总结
To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies
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
- •Patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e., IPSS ≥ 1.5] or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible. Patients with relapsed or refractory lymphoma or myeloma may also participate.
- •Age ≥18 years.
- •Adequate performance status
- •Interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. If the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable).
- •Persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or NCI CTCAE Grade < 1
- •Adequate laboratory results within 10 days of ENMD-2076 administration (unless the abnormality is considered attributable to leukemia)
排除标准
- •Pregnant or breast-feeding women.
- •Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
- •Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. Blood pressure must be < 150/90 at the time of enrollment.
- •Receiving any other treatment for their disease
- •QTc prolongation defined as ≥ 470 ms.
研究组 & 干预措施
1
Experimental
干预措施: ENMD-2076 (Drug)
结局指标
主要结局
Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events
时间窗: Day 1 through first cycle of therapy
次要结局
- Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies(monthly)
- Safety and toxicity of repeated oral dosing of ENMD 2076(Throughout study participation)
研究者
研究点 (1)
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