Overview
MK0457 in Patients With Leukemia (0457-003)
Status:
Completed
Completed
Trial end date:
2008-05-01
2008-05-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
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