A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) Who have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy.

Trial Profile

A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) Who have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy.

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Omacetaxine mepesuccinate (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors ChemGenex Pharmaceuticals; Teva Pharmaceutical Industries
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 13 Feb 2014 The US FDA has approved omacetaxine mepesuccinate for injection based on results from this and another pivotal phase II trial according to a Teva Pharmaceuticals Industries media release.
    • 11 Dec 2013 New source identified and integrated (Clinical Trials Registry - India; CTRI2013-11-004124).
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