Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2005-06-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MK-0457
Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration
MK0457
Interventions
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MK0457
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Giles FJ, Swords RT, Nagler A, Hochhaus A, Ottmann OG, Rizzieri DA, Talpaz M, Clark J, Watson P, Xiao A, Zhao B, Bergstrom D, Le Coutre PD, Freedman SJ, Cortes JE. MK-0457, an Aurora kinase and BCR-ABL inhibitor, is active in patients with BCR-ABL T315I leukemia. Leukemia. 2013 Jan;27(1):113-7. doi: 10.1038/leu.2012.186. Epub 2012 Jul 9.
Other Identifiers
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2005_033
Identifier Type: -
Identifier Source: secondary_id
0457-003
Identifier Type: -
Identifier Source: org_study_id
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