drugset

drugset / Trial / NCT00462943

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

NCT00462943 ↗

Phase 2 Completed 100 enrolled Teva Branded Pharmaceutical Products R&D, Inc. Cephalon · collab ChemGenex Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Publications

Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Homoharringtonine	Small molecule	1.25 mg/m2	Subcutaneous

Indications