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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: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 16 Jun 2019

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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

    • 04 Jun 2019 Results assessing tolerability of IVO in elderly patients with newly diagnosed acute myeloid leukemia, presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
    • 02 May 2019 According to an Agios Pharmaceuticals media release, based on the data from 28 newly diagnosed patients of this study the U.S. FDA approved a sNDA to update the U.S. Prescribing Information for TIBSOVO to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation.
    • 16 Mar 2019 Safety results (n=253) presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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