A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
研究概览
简要总结
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
详细描述
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when administered to patients with advanced myeloid leukemia.
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
- •Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy
- •ECOG performance status of 0-2
- •Acceptable organ and marrow function during the screening period as defined by the protocol
- •Reliable venous access suitable for study drug infusions
排除标准
- •Significant cardiovascular disease
- •Candidates for hematopoietic stem cell transplant
- •Women who are pregnant or breast-feeding
- •Prior treatment with chronic immunosuppressants
- •Other clinically significant uncontrolled conditions
研究组 & 干预措施
Elesclomol Sodium
干预措施: Elesclomol Sodium (Drug)
结局指标
主要结局
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
时间窗: 1 year
- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
Measurement of study drug concentrations to characterize pharmacokinetics.
时间窗: 1 year
- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
次要结局
- Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow(1 year)