A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

Trial Profile

A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

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

Latest Information Update: 06 Apr 2018

At a glance

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

    • 02 Apr 2018 Planned primary completion date changed from 31 May 2018 to 31 Dec 2018.
    • 12 Dec 2017 Results (data cut off: 14 Oct, 2016, n=214) assessing response and survival outcomes in patients with mutant-IDH2 (mIDH2) relapsed or refractory acute myeloid leukemia, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 28 Nov 2017 Planned End Date changed from 31 Dec 2018 to 31 May 2019.
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