Omacetaxine mepesuccinate

Generic Name
Omacetaxine mepesuccinate
Brand Names
Synribo
Drug Type
Small Molecule
Chemical Formula
C29H39NO9
CAS Number
26833-87-4
Unique Ingredient Identifier
6FG8041S5B
Background

Omacetaxine mepesuccinate (formerly known as HHT or Homoharringtonine), is a cephalotaxine ester and protein synthesis inhibitor with established clinical activity as a single agent in hematological malignancies. Omacetaxine mepesuccinate is synthesized from cephalotaxine, which is an extract from the leaves of the plant, Cephalotaxus species. In October 200...

Indication

Used in patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.

Associated Conditions
Refractory, accelerated phase Chronic myeloid leukemia, Refractory, chronic phase Chronic myeloid leukemia
Associated Therapies
-
Clinical Trials
Related News

AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

First Posted Date
2015-05-12
Last Posted Date
2021-07-06
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
22
Registration Number
NCT02440568
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)

Phase 1
Terminated
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Omacetaxine mepesuccinate
First Posted Date
2014-03-05
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
10
Registration Number
NCT02078960
Locations
🇺🇸

Teva Investigational Site 12545, Jacksonville, Florida, United States

🇺🇸

Teva Investigational Site 12550, Atlanta, Georgia, United States

🇺🇸

Teva Investigational Site 12543, Indianapolis, Indiana, United States

and more 7 locations

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

First Posted Date
2014-01-07
Last Posted Date
2016-05-09
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
2
Registration Number
NCT02029417
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate

First Posted Date
2013-05-01
Last Posted Date
2015-01-30
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
6
Registration Number
NCT01844869
Locations
🇳🇱

Teva Investigational Site 38045, Amsterdam, Netherlands

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

Phase 2
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Omacetaxine mepesuccinate
First Posted Date
2007-04-19
Last Posted Date
2021-12-28
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
100
Registration Number
NCT00462943
Locations
🇨🇦

Teva Investigational Site 313, Montreal, Canada

🇫🇷

Teva Investigational Site 327, Strasbourg, France

🇺🇸

Teva Investigational Site 303, Los Angeles, California, United States

and more 26 locations

Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

Phase 2
Completed
Conditions
Chronic Myeloid Leukemia
Interventions
Drug: Omacetaxine mepesuccinate
First Posted Date
2006-09-12
Last Posted Date
2021-11-15
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
103
Registration Number
NCT00375219
Locations
🇺🇸

Teva Investigational Site 003, Los Angeles, California, United States

🇫🇷

Teva Investigational Site 029, Bordeaux, France

🇫🇷

Teva Investigational Site 021, Le Chesnay Cedex, France

and more 29 locations

Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

First Posted Date
2005-06-21
Last Posted Date
2015-01-15
Lead Sponsor
ChemGenex Pharmaceuticals
Target Recruit Count
15
Registration Number
NCT00114959
Locations
🇺🇸

Univ. of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

First Posted Date
2004-08-10
Last Posted Date
2013-02-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
87
Registration Number
NCT00002574
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

First Posted Date
2004-04-30
Last Posted Date
2012-07-30
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
90
Registration Number
NCT00003239
Locations
🇺🇸

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa

Phase 3
Terminated
Conditions
Leukemia
Interventions
Drug: hydroxyurea
Drug: Homoharringtonine
First Posted Date
2004-04-28
Last Posted Date
2016-07-04
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
5
Registration Number
NCT00004933
Locations
🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

🇺🇸

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

🇺🇸

CCOP - Central Illinois, Decatur, Illinois, United States

and more 130 locations
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