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A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

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Trial Profile

A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2022

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At a glance

  • Drugs Azacitidine (Primary) ; Eprenetapopt (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Aprea Therapeutics

    • Most Recent Events

    • 12 Aug 2021 According to an Aprea Therapeutics media release, Based on initial feedback from the FDA and the partial clinical hold on its myeloid malignancy programs, the Company believes that there is no registrational pathway for this Phase 3 trial.
    • 28 Jul 2021 Planned End Date changed from 1 Jun 2021 to 1 Dec 2021.
    • 06 May 2021 According to an Aprea Therapeutics media release, the Company believes that dose modifications of eprenetapopt and azacitidine led to undertreatment in the Phase 3 experimental arm that negatively impacted efficacy, particularly the primary endpoint of CR rate. The Company continues to follow patients who remain on-study and anticipates discussing with FDA the Phase 3 data and future possible regulatory pathways in the second half of 2021.

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