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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 7, 2007

Primary Completion Date

August 4, 2009

Study Completion Date

June 27, 2013

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."

Trial Locations (29)

1096

Teva Investigational Site 350, Budapest

10117

Teva Investigational Site 331, Berlin

10466

Teva Investigational Site 302, The Bronx

14263

Teva Investigational Site 305, Buffalo

19111

Teva Investigational Site 310, Philadelphia

21201

Teva Investigational Site 311, Baltimore

31059

Teva Investigational Site 325, Toulouse

33076

Teva Investigational Site 329, Bordeaux

41038

Teva Investigational Site 390, Bologna

46107

Teva Investigational Site 308, Beech Grove

59000

Teva Investigational Site 322, Lille

67100

Teva Investigational Site 327, Strasbourg

68169

Teva Investigational Site 330, Mannheim

69437

Teva Investigational Site 320, Lyon

75475

Teva Investigational Site 328, Paris

77030

Teva Investigational Site 301, Houston

78157

Teva Investigational Site 321, Le Chesnay

86021

Teva Investigational Site 323, Poitiers

90033

Teva Investigational Site 303, Los Angeles

98109

Teva Investigational Site 314, Seattle

169608

Teva Investigational Site 380, Singapore

500082

Teva Investigational Site 371, Hyderabad

H3a 1a1

Teva Investigational Site 313, Montreal

M5G 2M9

Teva Investigational Site 309, Toronto

06202

Teva Investigational Site 324, Nice

400 014

Teva Investigational Site 370, Mumbai

80-952

Teva Investigational Site 360, Gdansk

02776

Teva Investigational Site 361, Warsaw

W12 0HS

Teva Investigational Site 340, London

Sponsors
All Listed Sponsors
collaborator

Cephalon

INDUSTRY

collaborator

ChemGenex Pharmaceuticals

INDUSTRY

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY