Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)

Inclusion Criteria

• •Men and women who are over 18 years of age and have one of the following conditions:
• •* AML with relapse within 12 months of the completion of consolidation therapy who are not to receive gemtuzumab-ozogamicin; or
• •* AML with relapse after 12 months of the completion of consolidation therapy for whom, in the opinion of the investigator, the risk of alternative therapy outweighs the possible benefit; or
• •* newly diagnosed AML refractory to conventional remission-induction chemotherapy ("refractory" is defined as \>10% blasts in blood and/or bone marrow upon recovery from two cycles of standard cytarabine-based induction chemotherapy); or
• •* newly diagnosed, or previously treated AML, greater than 60 years of age and not or no longer a candidate for conventional remission-induction chemotherapy or gemtuzumab-ozogamicin
• •No reproductive potential (surgically, post- menopausal, or using two methods of contraception)
• •Demonstrated FLT-3 gene, internal tandem duplication mutation
• •ECOG performance status of 0 to 2
• •Has not received cytoreductive drug therapy for at least 4 weeks, and has not received hydroxyurea within 24 hours prior to first dose of the study drug
• •Has not received a bone marrow transplant or peripheral blood stem cell transplant within the last two months
• •Able to read and give written informed consent and has signed a consent form approved by the Investigator's Institutional Review Board (IRB)