Relapsed/Refractory AML Clinical Trial
Official title:
A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine
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.
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.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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