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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2024

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At a glance

  • Drugs Ivosidenib (Primary)
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ClarIDHy
  • Sponsors Agios Pharmaceuticals

    • Most Recent Events

    • 01 May 2024 Results of pharmacokinetic (PK)/pharmacodynamic (PD) findings from the phase III ClarIDHy study and any association between PK/PD parameters and treatment outcomes in this population, published in the Cancer Chemotherapy and Pharmacology
    • 11 May 2023 According to a CStone Pharmaceuticals media release, Servier, a partner of CStone Pharmaceuticals announced European Commission approved Tuosuvo (ivonib tablets) for the treatment of patients with IDH1-mutated acute myeloid leukemia and cholangiocarcinoma.
    • 15 Mar 2023 According to a CStone Pharmaceuticals media release, MAA approval is expected in E.U. in 2023.

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