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A Phase 1b/2 Study To Evaluate The Safety And Efficacy Of Pf-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-c Or Decitabine In Patients With Acute Myeloid Leukemia Or High-risk Myelodysplastic Syndrome

Description

Phase

N/A

Inclusion and Exclusion Criteria

  • Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated.
  • Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML.
  • AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML)
  • For a diagnosis of AML, a bone marrow blast count of 20% or more is required.
  • For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts
  • Adequate Organ Function
  • ECOG Performance Status 0, 1, or 2

  • AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.
  • Patients with known active uncontrolled central nervous system (CNS) leukemia.

Sites

  • California

    • Pfizer Investigational Site, Los Angeles, California, 90095
    • Pfizer Investigational Site, Carlsbad, California, 92008
    • Pfizer Investigational Site, La Jolla, California, 92093
  • Washington

    • Pfizer Investigational Site, Seattle, Washington, 98195
  • Kansas

    • Pfizer Investigational Site, Kansas City, Kansas, 66160
    • Pfizer Investigational Site, Fairway, Kansas, 66205
    • Pfizer Investigational Site, Westwood, Kansas, 66205
  • Texas

    • Pfizer Investigational Site, Houston, Texas, 77030
  • Missouri

    • Pfizer Investigational Site, Creve Coeur, Missouri, 63141
    • Pfizer Investigational Site, St. Louis, Missouri, 63110
    • Pfizer Investigational Site, Saint Louis, Missouri, 63110
  • Illinois

    • Pfizer Investigational Site, Chicago, Illinois, 60637
    • Pfizer Investigational Site, Chicago, Illinois, 60611
  • Tennessee

    • Pfizer Investigational Site, Nashville, Tennessee, 37203
  • Alabama

    • Pfizer Investigational Site, Birmingham, Alabama, 35249
    • Pfizer Investigational Site, Birmingham, Alabama, 35294
    • Pfizer Investigational Site, Birmingham, Alabama, 35233
  • Indiana

    • Pfizer Investigational Site, Indianapolis, Indiana, 46214
  • Germany

    • Pfizer Investigational Site, Magdeburg, 39120
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