MK0457 in Patients With Leukemia (0457-003)

A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.

Inclusion Criteria:

Part 1:

• Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis

Part 2:

• Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
• At least 2 weeks since the last cytotoxic therapy
• Acceptable renal and hepatic function
• Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
• More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

Exclusion Criteria:

• Not fully recovered from previous anti-leukemia therapy
• Previous allogeneic bone marrow transplant
• Uncontrolled congestive heart failure
• Myocardial infarction within the last 3 months
• Active or uncontrolled infection
• Pregnancy or lactation
• Currently active second malignancy, other than non-melanoma skin cancer
• History of hepatitis B or C, known HIV positivity, or AIDS related illness