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

NCT01258816 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-09-23

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory AML

Interventions

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.

Sponsors & Collaborators

  • Theradex

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • CardiaBase

    collaborator OTHER

  • Learn & Confirm

    collaborator UNKNOWN

  • Clavis Pharma

    lead INDUSTRY

Principal Investigators

  • Steven Knapper, MD · Cardiff University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258816 on ClinicalTrials.gov