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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04164901
Study type Interventional
Source Servier
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 5, 2020
Completion date August 2027

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