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: 02 Aug 2017

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 Aug 2017 Results published in an Celgene Corporation media release.
    • 01 Aug 2017 According to an FDA media release, the US FDA has approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The approval was based on the results of this trial.
    • 25 Jun 2017 Results assessing differentiation syndrome associated with enasidenib in patients with relapsed/refractory acute myeloid leukaemia using patient data from NCT02577406 and NCT01915498 trials, presented at the 22nd Congress of the European Haematology Association
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