A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants
Completed
Agios Pharmaceuticals, Inc.
Phase 1
2019-10-02
The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in
healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of
AG-881.
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Recruiting
Agios Pharmaceuticals, Inc.
Phase 3
2020-01-05
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled
study comparing the efficacy of vorasidenib to placebo in participants with residual or
recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their
only treatment. Participants will be required to have central confirmation of IDH mutation
status prior to randomization. Approximately 340 participants are planned to be randomized
1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Recruiting
Institut de Recherches Internationales Servier
Phase 3
2020-01-05
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled
study comparing the efficacy of vorasidenib to placebo in participants with residual or
recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their
only treatment. Participants will be required to have central confirmation of IDH mutation
status prior to randomization. Approximately 340 participants are planned to be randomized
1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Astrocytomas
Not yet recruiting
Merck Sharp & Dohme LLC
Phase 1
2022-08-15
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive
enhancing isocitrate dehydrogenase-1 (IDH-1) mutant astrocytomas.
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