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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Omacetaxine mepesuccinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00462943

2007-001286-15 (EudraCT Number)

CGX-635-CML-203

Details and patient eligibility

About

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.

Full 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 failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

OMA

Experimental group

Description:

Omacetaxine mepesuccinate (OMA) Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days for up to six cycles. Omacetaxine mepesuccinate (OMA) Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days for up to 24 months.

Treatment:

Drug: Omacetaxine mepesuccinate