MK0457 in Patients With Leukemia (0457-003)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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