MedTrace Logo

Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

NCT00462943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-28

Study results available
· View outcomes & findings →

Summary

A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Omacetaxine mepesuccinate

Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days. Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days. Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • ChemGenex Pharmaceuticals

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Jorge Cortes, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-07
Primary Completion
2009-08-04
Completion
2013-06-27

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Poland
  • Singapore
  • United Kingdom

Study Locations

More Related Trials

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 NCT00462943 on ClinicalTrials.gov