A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 12
- 主要终点
- Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia
研究概览
简要总结
The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The efficacy and tolerability of elacytarabine will also be assessed.
详细描述
Elacytarabine is an investigational drug which is not commercially available. It consists of a fatty acid that is connected to cytarabine which is commonly used in treatment of AML. Due to the connection to a fatty acid, elacytarabine might have an increased uptake in blast cells and thereby increased efficacy.
The characterisation of the pharmacokinetics of an investigational drug, as well as the cardiac safety are essential. The PK of both elacytarabine and its metabolites will be assessed at defined timepoints before, during and after infusion. The cardiac safety of elacytarabine will be evaluated by triplicate ECG recordings at the same time points as the PK assessments.
Elacytarabine will be given as a continuous infusion for 5 days. The patients may continue with further courses of elacytarabine as long as the patient benefits from treatment with elacytarabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- •A history of allergic reactions to egg. A history of CTCAE grade 3 or 4 allergic reactions to ara-C of
- •A history of cancer that according to the investigator might confound the assessment of the endpoints of the clinical study
- •Known positive status for human immunodeficiency virus (HIV)
- •Pregnant and nursing patients
- •Uncontrolled inter-current illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that will limit compliance with study requirements
- •Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into the clinical study
- •Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medications, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
- •A history of familial long QT syndrome
- •Patients with history of serious ventricular arrhythmia (VT or VT)
- •ECG criteria at the eligibility visit: QTc ≥ 480 msec calculated using Fridericia's correction (QTcF = QT/RRO,33) or bradycardia (<50bpm) or criteria for left ventricular hypertrophy
- •treatment with any medications known to produce QT prolongations
- •Treatment with hydroxyurea or 6-mercaptopurine within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days
- •Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
结局指标
主要结局
Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia
时间窗: During first week of treatment course
Collection of pheripheral blood samples at specified time points during first week of the treatment course for PK analyses
次要结局
- Investigate the activity of elacytarabine measured as remission rate (CR + CRi)(After each course)
- Number of patients with Adverse Events as a measure of safety and tolerability(Continuously during study)
- Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals(During the first week of treatment)