Status:
COMPLETED
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborating Sponsors:
Cephalon
ChemGenex Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 f...
Eligibility Criteria
Inclusion
- Male or female patients, age 18 years or older
- Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
- Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
- Acceptable Renal and Liver Function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Sexually active patients and their partners must use an effective double barrier method of contraception
Exclusion
- New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
- Myocardial infarction in the previous 12 weeks.
- Other concurrent illness which would preclude study conduct and assessment
- uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
- Pregnant or lactating.
- Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
- Lymphoid Ph+ blast crisis
- Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
Key Trial Info
Start Date :
March 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00462943
Start Date
March 7 2007
End Date
June 27 2013
Last Update
December 28 2021
Active Locations (29)
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1
Teva Investigational Site 303
Los Angeles, California, United States, 90033
2
Teva Investigational Site 308
Beech Grove, Indiana, United States, 46107
3
Teva Investigational Site 311
Baltimore, Maryland, United States, 21201
4
Teva Investigational Site 305
Buffalo, New York, United States, 14263