Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Фаза 3
Идёт, набор закрыт
NCT04164901
| Заболевание | Grade 2 Glioma, Residual Glioma, Recurrent Glioma |
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| Фаза | Фаза 3 |
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| Спонсор | Institut de Recherches Internationales Servier |
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| Статус | Идёт, набор закрыт |
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| Участники | 331 участн. |
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| Вмешательство | Vorasidenib, Matching Placebo |
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| Дата начала | 5.01.2020 |
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| Дата завершения | 6.09.2022 |
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| Публикация результатов | 24.11.2023 |
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Кратко
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.
Progression-Free Survival (PFS)
Up to approximately 30 months · months
| Vorasidenib | 27.7 months |
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| Matching Placebo | 11.1 months |
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| p-value | <0.0000001 |
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| Cox Proportional Hazard | 0.39 (95% CI 0.27–0.56) |
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