Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Public ClinicalTrials.gov record NCT04164901. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04164901
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 331 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 5, 2020 (Actual)
- Primary completion
- Sep 6, 2022 (Actual)
- Completion
- May 2028 (Estimated)
- Last update posted
- Apr 3, 2025
2020 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 25
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| City of Hope | Duarte | California | 91010 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| UCLA Oncology Center | Los Angeles | California | 90095 | — |
| University of California Irvine - Hospital | Orange | California | 92868 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| Yale University, Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics | Miami | Florida | 33136 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Maine Medical Partners Neurology | Scarborough | Maine | 04074 | — |
| John Hopkins Cancer Center | Baltimore | Maryland | 21231 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Metro Minnesota Community Oncology | Minneapolis | Minnesota | 55416 | — |
| Mayo Comprehensive Cancer | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The University of Utah, Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04164901, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04164901 live on ClinicalTrials.gov.