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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Collaborators: Cephalon; ChemGenex Pharmaceuticals
• Treatments: Harringtonines; Homoharringtonine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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