NCT00543972终止1 期
An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Incidence of Dose Limiting Toxicity(ies) at each tested dose level
研究概览
简要总结
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.
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 with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
- •ECOG performance status 0 to 2
排除标准
- •Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
- •Allogenic transplantation within 6 months prior to inclusion
- •Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
- •Previous treatment with AVE9633
- •Poor kidney, liver and bone marrow functions
- •Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
- •Pregnant or breast-feeding women
- •Patient with reproductive potential without effective birth control methods
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
时间窗: Study period
次要结局
- Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance(Study period)
- Incidence of Adverse Events(Study period)
研究者
研究点 (3)
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