NCT01258816

The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055)

A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsed/Refractory AML

Interventions

Type	Name	Description
DRUG	Elacytarabine for infusion	Elacytarabine 2000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w schedule.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2010-12-13
• Last updated: 2013-09-23

Locations

6 sites across 2 countries: Spain, United Kingdom