Omacetaxine plus Gleevec®

CGX-635-CML-201 is a phase 2 open-label study to evaluate the efficacy and safety of intravenous administration of omacetaxine combined with the oral administration of imatinib mesylate (Gleevec®) in the treatment of patients with chronic myeloid leukemia (CML) in chronic, accelerated and blast phase.

Approximately 50 patients will be enrolled in the study being conducted at the M.D. Anderson Cancer Center, in Houston, Texas, U.S.A.

Who can participate?

Selected inclusion criteria:

• Male or female patients 16 years or older
• Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase.
• Patients with chronic phase CML will be either refractory or resistant to prior imatinib mesylate therapy.
• Patients with accelerated or blast phase may be newly diagnosed and previously untreated or if previously treated with imatinib mesylate, will be refractory to or resistant to this agent or have failed to achieve at least a complete hematologic or cytogenetic response to treatment.
• ECOG performance status 0-2.

Selected exclusion criteria:

• NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure.
• Myocardial infarction in the previous 12 weeks.
• Pregnant or lactating.
• Other concurrent illness which would preclude study conduct and assessment, including but not limited to another active malignancy, uncontrolled and active infection, positive HIV status or positive HTLV I/II status.
• Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.

Please note there are other additional criteria. The study center will determine if you meet all of the requirements for enrollment.

For further information on the CGX-635-201 study please contact the ChemGenex clinical trials group at 1-650-474-9800, ext. 108 or e-mail us at clinicaltrials@chemgenex.com.

Disclosure of Risks

Please note that the safety and effectiveness of this product have not yet been established. As with other anti-cancer treatments, this investigational product may not benefit you and may cause side effects. These side effects could be severe or even life threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study.