Omacetaxine Multi-TKI Resistance

CGX-635-CML-203 is a multi-center phase 2 open-label study to evaluate the efficacy and safety of subcutaneous administration of omacetaxine in the treatment of patients with chronic myeloid leukemia (CML) in chronic, accelerated and blast phase who have failed, or are intolerant to, two or more tyrosine kinase inhibitors.

Up to 75 patients will be enrolled in the study. Study centers are listed on the clinicaltrials.gov website. A linked is provided below.

Study design

• Open-label, multi-center phase 2 clinical trial, conducted in the USA and in Europe.
• Remission induction phase (home treatment): omacetaxine 1.25 mg/m2 by subcutaneous injection two times a day for 14 consecutive days, repeated every 28 days.
• Remission maintenance phase (home treatment): omacetaxine 1.25 mg/m2 subcutaneous injection two times a day for 7 consecutive days, repeated every 28 days.
• Patients will be stratified upon whether they have chronic phase (CP), accelerated phase (AP), or blast phase (BP) CML.
• Up to 75 patients will be enrolled into the study.

Who can participate?

Selected 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).
• Patients must have completed all previous anti-leukemic therapy for at least 2 weeks, prior to the first planned dose of omacetaxine and must have fully recovered from side effects of a previous therapy, unless disease progression necessitates early therapy.
• 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.
• Lymphoid Ph+ blast crisis.

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-CML-203 study please contact the ChemGenex clinical trials group at 1-650-474-9800, ext. 108 or e-mail us at clinicaltrials@chemgenex.com.

Key Primary and Secondary Efficacy Endpoints

• Hematologic and cytogenetic response rates, respectively.

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.