WHO ICTRP trial

Open Label Study of Subcutaneous Omacetaxine in Patients With Advanced Chronic…

ACTRN12609000377235 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting

Key facts

Trial ID ACTRN12609000377235
Public title Open Label Study of Subcutaneous Omacetaxine in Patients With Advanced Chronic Myeloid Leukemia.
Scientific title A Phase II Open-Label Study of the Subcutaneous Administration of Omacetaxine in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy.
Primary sponsor ChemGenex Pharmaceuticals Inc.
Registry Australian New Zealand Clinical Trials Registry (ANZCTR)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 2 / Phase 3
Countries Australia;United States of America;Canada;France;Germany;United Kingdom;Hungary;Poland;Singapore;India
Conditions Chronic Myeloid Leukemia; Chronic Myeloid Leukemia;Cancer - Leukaemia - Chronic leukaemia
Interventions Omacetaxine mepesuccinate Patient will be treated with omacetaxine in treatment cycles of 28 days duration. There will be no breaks between treatment cycles and the cycles will continue for upto 24 months. Dose = 1.25 mg/m2 twice daily for…
Registration date May 28, 2009
Target size 100
Secondary IDs CGX-635-CML-203 (ChemGenex Pharmaceuticals);ClinicalTrials.gov, NCT00462943
Registry page anzctr.org.au

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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