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A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Phase 1
18 Years
Not Enrolling
Chronic Myelogenous Leukemia in Blast Crisis, Lymphocytic Leukemia, B Cell, Acute, Myelodysplastic Syndromes, Myelogenous Leukemia, Chronic

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Trial Information

A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

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

- 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

- More than 2 months since autologous bone marrow or peripheral blood stem cell

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of MK0457 as 5 day infusion measured by duration, grade, and time of onset of toxicity. Plasma pK levels by dose level.

Outcome Time Frame:

30 Months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

May 2008

Related Keywords:

  • Chronic Myelogenous Leukemia in Blast Crisis
  • Lymphocytic Leukemia, B Cell, Acute
  • Myelodysplastic Syndromes
  • Myelogenous Leukemia, Chronic
  • Myelodysplastic Syndrome[Refractory Anemia with
  • Excess Blasts-1 or 2 (WHO Classification)]
  • Chronic Myelogenous Leukemia in blast crisis
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Chronic Disease
  • Leukemia, B-Cell