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

Trial Status: Closed to Accrual

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Brian Andrew Jonas
Phone: 916-734-3089

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Daniel A. Pollyea
Phone: 720-848-0650

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Martha Lucia Arellano
Phone: 404-778-1868

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Michael J. Thirman
Phone: 773-834-7424

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Anthony George Letai
Phone: 866-790-4500

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Mark Gerard Frattini
Phone: 212-305-8615

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Contact: David Alan Rizzieri
Phone: 919-668-1040

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Pamela Sue Becker

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Abbvie

  • Primary ID M14-358
  • Secondary IDs NCI-2014-01763, 2014-000687-18
  • Clinicaltrials.gov ID NCT02203773