Spots Global Cancer Trial Database for Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
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Trial Identification
Brief Title: Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Official Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients With Chronic Myeloid. Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy
Study ID: NCT00462943
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Teva Investigational Site 303, Los Angeles, California, United States
Teva Investigational Site 308, Beech Grove, Indiana, United States
Teva Investigational Site 311, Baltimore, Maryland, United States
Teva Investigational Site 302, Bronx, New York, United States
Teva Investigational Site 305, Buffalo, New York, United States
Teva Investigational Site 310, Philadelphia, Pennsylvania, United States
Teva Investigational Site 301, Houston, Texas, United States
Teva Investigational Site 314, Seattle, Washington, United States
Teva Investigational Site 313, Montreal, , Canada
Teva Investigational Site 309, Toronto, , Canada
Teva Investigational Site 329, Bordeaux, , France
Teva Investigational Site 321, Le Chesnay Cedex, , France
Teva Investigational Site 322, Lille, , France
Teva Investigational Site 320, Lyon Cedex 03, , France
Teva Investigational Site 324, Nice, , France
Teva Investigational Site 328, Paris, , France
Teva Investigational Site 323, Poitiers Cedex, , France
Teva Investigational Site 327, Strasbourg, , France
Teva Investigational Site 325, Toulouse, , France
Teva Investigational Site 331, Berlin, , Germany
Teva Investigational Site 330, Mannheim, , Germany
Teva Investigational Site 350, Budapest, , Hungary
Teva Investigational Site 371, Hyderabad, , India
Teva Investigational Site 370, Mumbai, , India
Teva Investigational Site 390, Bologna, , Italy
Teva Investigational Site 360, Gdansk, , Poland
Teva Investigational Site 361, Warszawa, , Poland
Teva Investigational Site 380, Singapore, , Singapore
Teva Investigational Site 340, London, , United Kingdom
Contact Details
Name: Jorge Cortes, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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