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A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Trial Profile

A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Ivosidenib (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Agios Pharmaceuticals
  • Most Recent Events

    • 24 Oct 2023 According to a Servier media release, the U.S. Food and Drug Administration (FDA) has approved TIBSOVO (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS),based on data from this trial.
    • 15 Aug 2023 According to a Servier media release, the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for TIBSOVO (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS), based on data from this trial.
    • 15 Jun 2023 Results (n=19) assessing the safety, tolerability, and clinical activity of IVO in pts with mIDH1 R/R MDS presented at the 28th Congress of the European Haematology Association

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