IMLEU22004 / ASTX727-07 / Liesveld
Basic Study Information
Purpose:
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and
efficacy of ASTX727 when given in combination with venetoclax for the treatment of
newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older,
or who have comorbidities that preclude use of intensive induction chemotherapy. The
primary purpose of the study is to rule out drug-drug interactions between ASTX727
and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum
plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess
the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential
PK interactions. Phase 2 will follow the same overall study design as Phase 1 and
has two parts, Part A and Part B.
Location: University of Rochester
Lead Researcher (Principal Investigator)
Lead Researcher:
Jane Liesveld, MD
Study Contact Information
Study Contact: Clinical Trials Office
Study Location: Wilmot Cancer Institute, University of Rochester Medical Center
Study Email: WCICTOResearch@urmc.rochester.edu
Additional Study Details
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