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

Sponsor
Clavis Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01258816
Collaborator
Theradex (Industry), Syneos Health (Other), CardiaBase (Other), Learn & Confirm (Other)
43
Enrollment
6
Locations
32
Duration (Months)
7.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
  • 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
Actual Enrollment :
43 participants
Allocation:
N/A
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 :
Oct 1, 2010
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia [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) [After each course]

    Bone marrow and/or blood examination

  2. Number of patients with Adverse Events as a measure of safety and tolerability [Continuously during study]

  3. Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ICO - Hospital Duran i Reynals Barcelona Catalunya Spain 08907
2 Hospital General de la Vall d' Hebron Barcelona Spain 08035
3 Hospital San Pedro Alcantara Cáceres Spain 10003
4 Brighton & Sussex University Hospitals NHS Trust Brighton United Kingdom BN2 5BE
5 University Hospital of Wales, Cardiff Cardiff United Kingdom CF14 4XW
6 St Bartholomew's Hospital London United Kingdom EC1A 7BE

Sponsors and Collaborators

  • Clavis Pharma
  • Theradex
  • Syneos Health
  • CardiaBase
  • Learn & Confirm

Investigators

  • Principal Investigator: Steven Knapper, MD, Cardiff University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT01258816
Other Study ID Numbers:
  • CP4055-109
First Posted:
Dec 13, 2010
Last Update Posted:
Sep 23, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Clavis Pharma
Acute Myeloid Leukaemia (AML)
Pharmacokinetics
Elacytarabine
CP-4055

Study Results

No Results Posted as of Sep 23, 2013