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
Study Drug
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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