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NCT04164901 · ClinicalTrials.gov registry record · Phase 3
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
A Phase 3 study of Recurrent Glioma and Grade 2 Glioma, sponsored by Institut de Recherches Internationales Servier.
- Active
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT04164901: Active Phase 3 study of Recurrent Glioma and Grade 2 Glioma, sponsored by Institut de Recherches Internationales Servier.
NCT04164901 is a Phase 3 study of Recurrent Glioma and Grade 2 Glioma that is active but no longer recruiting, run by Institut de Recherches Internationales Servier. The registered enrollment target is 331 participants, above the 42-participant average among 12 other Recurrent Glioma trials with a reported enrollment target (688% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04164901, a Phase 3 study of Recurrent Glioma and Grade 2 Glioma, is active but no longer recruiting, sponsored by Institut de Recherches Internationales Servier.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Vorasidenib
Study Locations (20)
California
- City of Hope - Duarte
- University of California San Diego - La Jolla
- UCLA Oncology Center - Los Angeles
- University of California Irvine - Hospital - Orange
- University of California San Francisco - San Francisco
- Stanford Cancer Center - Stanford
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics - Miami
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
Connecticut
- Yale University, Yale Cancer Center - New Haven
Indiana
- Indiana University Medical Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2020-01-05 |
| Est. Completion | 2028-05 |
| Phase | Phase 3 |
What the registry record for NCT04164901 still lists
NCT04164901 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, above the 42-participant average among 12 other Recurrent Glioma trials with a reported enrollment target (688% higher).
The record links to 3 conditions, with Recurrent Glioma appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04164901 names 20 study sites across 12 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT04164901 about?
NCT04164901 is a clinical study titled "Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)". 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 wi...
What is the current status of trial NCT04164901?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2020-01-05. Estimated completion is 2028-05.
What conditions does trial NCT04164901 study?
This clinical trial studies the following conditions: Recurrent Glioma, Grade 2 Glioma, Residual Glioma.
What interventions are being tested in trial NCT04164901?
The interventions under investigation include: Matching Placebo (DRUG), Vorasidenib (DRUG).
Who is sponsoring clinical trial NCT04164901?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04164901 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04164901's enrollment target sits among peer trials
331 1st of 12 higher than 12 of 12 other Recurrent Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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