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A Phase 1 Study of Milademetan (DS 3032b), an Oral MDM2 Inhibitor, In Dose Escalation as a Single Agent and In Dose Escalation/Expansion In Combination With 5 Azacitidine In Subjects With Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

Trial Profile

A Phase 1 Study of Milademetan (DS 3032b), an Oral MDM2 Inhibitor, In Dose Escalation as a Single Agent and In Dose Escalation/Expansion In Combination With 5 Azacitidine In Subjects With Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Milademetan (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 14 May 2021 Status changed from active, no longer recruiting to discontinued.
    • 08 Dec 2020 Results assessing clonal expansion of mutant p53 clones by MDM2 inhibition in acute myeloid leukemias, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 08 May 2020 Status changed from recruiting to active, no longer recruiting.
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