Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

Study Identifier
M14-358
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Blood Cancer - Leukemia (Other)
  • Study Drug
  • Posaconazole
  • ABT-199
  • Decitabine
  • Azacitidine
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    60+ years

    Protocol Summary

    This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 129718
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    University of California, Davis Comprehensive Cancer Center /ID# 129719
    Sacramento, California, United States, 95817
    Status
    Not applicable
    Location
    Univ of Colorado Cancer Center /ID# 127859
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Emory Midtown Infectious Disease Clinic /ID# 129715
    Atlanta, Georgia, United States, 30322
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 128741
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    The University of Chicago Medical Center /ID# 128742
    Chicago, Illinois, United States, 60637-1443
    Status
    Not applicable
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