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

Stopped early · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Myelogenous Leukemia, Treatment Naive AML

In brief

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.

Key facts

Study ID

NCT02203773

Run by

AbbVie

People needed

212

Starts

2014-10-06

Expected to finish

2022-06-16

Last updated by the study team

2023-05-16

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
• Subject must have received no prior treatment for AML with the exception of hydroxyurea
• Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age
• Subject must have adequate kidney and liver function as described in the protocol

You may not qualify if…

• Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS])
• Subject has history of Myeloproliferative Neoplasm (MPN).
• Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML.
• Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.
• Subject has acute promyelocytic leukemia.
• Subject has known active central nervous system involvement with AML.
• Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
• Subject has a history of other malignancies prior to study entry, with the exception of:
• Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
• Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• Subject has a white blood cell count > 25 × 10\^9/L. Note: Hydroxyurea is permitted to meet this criterion.

Where it is running

• 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, 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-Wurttemberg, Germany
• Universitaetsklinikum Leipzig /ID# 130346 — Leipzig, Saxony, Germany
• Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 130342 — Dresden, Germany
• Duplicate_Klinikum Rechts der Isar /ID# 130347 — Munich, Germany

Full record on ClinicalTrials.gov

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