Status:
COMPLETED
MK0457 in Patients With Leukemia (0457-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Myelogenous Leukemia in Blast Crisis
Lymphocytic Leukemia, B Cell, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00111683
Start Date
June 1 2005
End Date
May 1 2008
Last Update
August 25 2015
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