NCT01258816

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2010

Typical duration for phase_1

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

November 26, 2010

Last Update Submit

September 20, 2013

Conditions

Relapsed/Refractory AML

Keywords

Acute Myeloid Leukaemia (AML)PharmacokineticsElacytarabineCP-4055

Outcome Measures

Primary Outcomes (1)

  • Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia

    Collection of pheripheral blood samples at specified time points during first week of the treatment course for PK analyses

    During first week of treatment course

Secondary Outcomes (3)

  • Investigate the activity of elacytarabine measured as remission rate (CR + CRi)

    After each course

  • Number of patients with Adverse Events as a measure of safety and tolerability

    Continuously during study

  • Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals

    During the first week of treatment

Interventions

Elacytarabine for infusionDRUG

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

Also known as: CP-4055

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • A history of allergic reactions to egg. A history of CTCAE grade 3 or 4 allergic reactions to ara-C of
  • A history of cancer that according to the investigator might confound the assessment of the endpoints of the clinical study
  • Known positive status for human immunodeficiency virus (HIV)
  • Pregnant and nursing patients
  • Uncontrolled inter-current illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that will limit compliance with study requirements
  • 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
  • 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
  • A history of familial long QT syndrome
  • Patients with history of serious ventricular arrhythmia (VT or VT)
  • 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
  • treatment with any medications known to produce QT prolongations
  • 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
  • \. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ICO - Hospital Duran i Reynals

Barcelona, Catalonia, 08907, Spain

Location

Hospital General de la Vall d' Hebron

Barcelona, 08035, Spain

Location

Hospital San Pedro Alcantara

Cáceres, 10003, Spain

Location

Brighton & Sussex University Hospitals NHS Trust

Brighton, BN2 5BE, United Kingdom

Location

University Hospital of Wales, Cardiff

Cardiff, CF14 4XW, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

  • Knapper S, Chevassut T, Duarte R, Bergua JM, Salamero O, Johansen M, Jacobsen TF, Hals PA, Rasch W, Gianella-Borradori A, Smith M. Elacytarabine in relapsed/refractory acute myeloid leukaemia: an evaluation of clinical efficacy, pharmacokinetics, cardiac safety and effects on lipid profile. Leuk Res. 2014 Mar;38(3):346-51. doi: 10.1016/j.leukres.2013.12.011. Epub 2013 Dec 25.

    PMID: 24433865DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

5'-oleoyl cytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Steven Knapper, MD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2010

First Posted

December 13, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

ES(3)GB(3)