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Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

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Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

          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.
        

Est. Enrollment: 124 participants

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The number of participants in a clinical study. The "estimated" enrollment is the target number of participants the researchers need for the study.

Study Start Date: Feb 09, 2021

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These are the dates the researchers think the study will start and end.

Study Completion Date: Jul 01, 2024

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The "estimated" study completion date is the date the researchers think the last participant in a clinical study was examined or received an intervention/treatment. This is also the expected date that the study will be completed

Age: 18+ years

Gender: All

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