Omacetaxine

CGX-635-MDS-201 is a phase 2 open-label study to evaluate the efficacy and safety of intravenous administration of omacetaxine in the treatment of patients with myelodysplastic syndrome (MDS).

Approximately 30 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 non-pregnant female patients 16 years or older.
• Diagnosed with primary (de novo) or secondary MDS.
• Patients must have received no more than one (1) prior regimen of conventional anticancer therapy for MDS.
• Patients with performance status 0-2 (Zubrod scale) and life expectancy greater than 4 weeks.

Selected exclusion criteria:

• Patients with outright acute leukemia for whom induction therapy is indicated.
• 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.
• Patients who have received prior high-dose ara-C, defined as therapy with ara-C at > 0.5 g/m2/dose for > 4 doses.
• 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-MDS-201 study please contact the ChemGenex clinical trials group at 1-800-877-3009, ext.112 or e-mail us at clinical@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 patients 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. Patients should discuss these risks with your physician or a study.