The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine|
- Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia [ Time Frame: During first week of treatment course ] [ Designated as safety issue: No ]Collection of pheripheral blood samples at specified time points for PK analyses
- Investigate the activity of elacytarabine measured as remission rate (CR + CRi) [ Time Frame: After each course ] [ Designated as safety issue: Yes ]Bone marrow and/or blood examination
- Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: Continuously during study ] [ Designated as safety issue: Yes ]
- Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals [ Time Frame: During the first week of treatment ] [ Designated as safety issue: No ]Triplicate 12-lead ECG assessments will be done at specified time points before, during and after infusion
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Drug: Elacytarabine for infusion
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.
|ICO - Hospital Duran i Reynals|
|Barcelona, Catalunya, Spain, 08907|
|Hospital General de la Vall d' Hebron|
|Barcelona, Spain, 08035|
|Hospital San Pedro Alcantara|
|Cáceres, Spain, 10003|
|Brighton & Sussex University Hospitals NHS Trust|
|Brighton, United Kingdom, BN2 5BE|
|University Hospital of Wales, Cardiff|
|Cardiff, United Kingdom, CF14 4XW|
|St Bartholomew's Hospital|
|London, United Kingdom, EC1A 7BE|
|Principal Investigator:||Steven Knapper, MD||Cardiff University|