Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04164901
The ClinicalTrials.gov registry entry for NCT04164901 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 42-participant average among 12 other Recurrent Glioma trials with a reported enrollment target (688% higher). The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
-
CARv3-TEAM-E T Cells in Glioblastoma
RECRUITING · Phase 1
-
A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma
RECRUITING · NA
-
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
RECRUITING · Phase 2
-
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
RECRUITING · NA
-
Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations
ACTIVE NOT RECRUITING · Phase 2
-
Niraparib In Recurrent IDH 1/2 Gliomas
ACTIVE NOT RECRUITING · Early Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.