Spots Global Cancer Trial Database for Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
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Trial Identification
Brief Title: Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
Official Title: A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy
Study ID: NCT02203773
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope /ID# 129718, Duarte, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 129719, Sacramento, California, United States
Univ of Colorado Cancer Center /ID# 127859, Aurora, Colorado, United States
Emory Midtown Infectious Disease Clinic /ID# 129715, Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 128741, Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 128742, Chicago, Illinois, United States
Johns Hopkins University /ID# 129699, Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 127857, Boston, Massachusetts, United States
Columbia University Medical Center /ID# 130289, New York, New York, United States
Duke Cancer Center /ID# 129720, Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center /ID# 127860, Houston, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 141581, Houston, Texas, United States
University of Washington /ID# 129717, Seattle, Washington, United States
St George Hospital /ID# 130356, Kogarah, New South Wales, Australia
Peter MacCallum Cancer Ctr /ID# 130352, Melbourne, Victoria, Australia
Alfred Health /ID# 130353, Melbourne, Victoria, Australia
Hopital Haut-Lévêque /ID# 134388, Pessac CEDEX, Gironde, France
Duplicate_Hopital Universitaire Purpan /ID# 134389, Toulouse, Haute-Garonne, France
AP-HP - Hopital Saint-Louis /ID# 130349, Paris, , France
Universitaetsklinikum Ulm /ID# 130341, Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Leipzig /ID# 130346, Leipzig, Sachsen, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 130342, Dresden, , Germany
Duplicate_Klinikum Rechts der Isar /ID# 130347, Munich, , Germany
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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