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Brief Title Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Official Title A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are ≥ 65 Years of Age and Who Are Not Eligible for Standard Induction Therapy
Principal Investigator Thirman, Michael
Brief Summary This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
Gender Both
Ages 65 Years
Enrollment 160
Accepts Healthy Volunteers No
Lead Sponsor AbbVieIndustry
Collaborator Genentech, Inc.Industry
Study Design Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name Site Reference ID/Investigator# 129718, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Myelogenous Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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