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

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ClinicalTrials.gov Identifier: NCT01258816
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : September 23, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory AML Drug: Elacytarabine for infusion Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine
Study Start Date : October 2010
Primary Completion Date : May 2013
Study Completion Date : June 2013


Arms and Interventions

Intervention Details:
    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.
    Other Name: CP-4055

Outcome Measures

Primary Outcome Measures :
  1. Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia [ Time Frame: 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


Secondary Outcome Measures :
  1. Investigate the activity of elacytarabine measured as remission rate (CR + CRi) [ Time Frame: After each course ]
    Bone marrow and/or blood examination

  2. Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: Continuously during study ]
  3. Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals [ Time Frame: During the first week of treatment ]
    Triplicate 12-lead ECG assessments will be done at specified time points before, during and after infusion


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion¨Criteria:

  1. Patients must have relapsed / refractory AML according to WHO classification (excluding acute promyelocytic leukaemia)
  2. Patients must have ECOG Performance Status (PS) of 0 - 2
  3. Patients must be 18 years of age or older
  4. Women of child-bearing potential must have a negative serum or urine pregnancy test within two weeks prior to treatment start
  5. Male and female fertile patients must use adequate contraception for the duration of the study, and males also for 3 months after the last elacytarabine dose
  6. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent

Exclusion Criteria:

  1. A history of allergic reactions to egg. A history of CTCAE grade 3 or 4 allergic reactions to ara-C of
  2. A history of cancer that according to the investigator might confound the assessment of the endpoints of the clinical study
  3. Known positive status for human immunodeficiency virus (HIV)
  4. Pregnant and nursing patients
  5. Uncontrolled inter-current illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that will limit compliance with study requirements
  6. 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
  7. 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
  8. A history of familial long QT syndrome
  9. Patients with history of serious ventricular arrhythmia (VT or VT)
  10. 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
  11. treatment with any medications known to produce QT prolongations
  12. 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

9. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258816


Locations
Spain
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
United Kingdom
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
Sponsors and Collaborators
Clavis Pharma
Theradex
INC Research
CardiaBase
Learn & Confirm
Investigators
Principal Investigator: Steven Knapper, MD Cardiff University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT01258816     History of Changes
Other Study ID Numbers: CP4055-109
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by Clavis Pharma:
Acute Myeloid Leukaemia (AML)
Pharmacokinetics
Elacytarabine
CP-4055

Additional relevant MeSH terms:
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs