Overview

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