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Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Mar 24, 2025, no change to tracked fieldsv29-v30
  2. Completion date: Aug 2027 to May 2028 Secondary endpoints: 1 to 11 · Study sites revised (84) · Publications: details revised at 1 of 2 entriesv28 Show 3 more changesShow less
    • Secondary endpoints: 1 to 11
    • Study sites revised (84)
    • Publications: details revised at 1 of 2 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv27
  4. Results first posted: Nov 24, 2023 Secondary endpoints: details revised at 1 of 1 entryv26 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  5. Enrollment target: estimated 340 to confirmed 331 Primary completion date changed from estimate of Oct 2024 to Sep 6, 2022 · Secondary endpoints: 14 to 1v25 Show 2 more changesShow less
    • Primary completion date changed from estimate of Oct 2024 to Sep 6, 2022
    • Secondary endpoints: 14 to 1

    See this version in full on ClinicalTrials.gov ↗

Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 83 to 84v24
  2. Study sites: 77 to 83v23
  3. Re-verified, no change to tracked fieldsv22
  4. Study sites: 79 to 77v21
  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 75 to 79v20 Show 1 more changeShow less
    • Study sites: 75 to 79
  6. Lead sponsor: Agios Pharmaceuticals, Inc. to Institut de Recherches Internationales Servier Study sites: 73 to 75v19 Show 1 more changeShow less
    • Study sites: 73 to 75
  7. Study sites: 70 to 73v18
  8. Study sites: 68 to 70 Completion date: Apr 2028 to Aug 2027v17 Show 1 more changeShow less
    • Completion date: Apr 2028 to Aug 2027
  9. Study sites: 65 to 68 Interventions: AG-881 (Drug), Matching Placebo (Drug) to Matching Placebo (Drug), Vorasidenib (Drug) · Eligibility criteria expanded, about 18 words · Secondary endpoints: 12 to 14 · 1 morev16 Show 4 more changesShow less
    • Interventions: AG-881 (Drug), Matching Placebo (Drug) to Matching Placebo (Drug), Vorasidenib (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 12 to 14
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Enrollment target: 366 to 340 Study sites: 60 to 65v15 Show 1 more changeShow less
    • Study sites: 60 to 65
  11. Study sites: 52 to 60v14
  12. Study sites: 44 to 52v13
  13. Study sites: 30 to 44v12
  14. Study sites: 25 to 30v11
  15. Study sites: 23 to 25v10
  16. Study sites: 15 to 23v9
  17. Study sites: 10 to 15v8
  18. Eligibility criteria expanded, about 22 wordsv7 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 5 to 10v6
  20. Study sites revised (5)v5 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 1 to 5 Start date changed from estimate of Dec 2019 to Jan 5, 2020v4 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2019 to Jan 5, 2020
  22. Trial status: Not Yet Recruiting to Recruitingv3
  23. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04164901
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Grade 2 Glioma, Residual Glioma, Recurrent Glioma
Enrollment 331 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov