Clinical trial · Interventional
MK0457 in Patients With Leukemia (0457-003)
A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia
NCT00111683CI-TRIAL-00018925completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia in Blast Crisis | — | UNRESOLVED | — |
| Lymphocytic Leukemia, B Cell, Acute | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelogenous Leukemia, Chronic | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK0457 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MK-0457
- description
- Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration
- interventionNames
- Drug: MK0457
Primary outcomes (1)
- measure
- Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
- timeFrame
- Part 1: up to 5 days, Part 2: up to 24 hours
Secondary outcomes (1)
- measure
- Hematological response rate to MK-0457 as a 5-day CIV infusion
- timeFrame
- At the end of each cycle (up to 18 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGiles 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. PMID 22772060