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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT04164901
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Grade 2 Glioma
  • Recurrent Glioma
  • Residual Glioma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    Vorasidenib oral film-coated tablets
  • Matching Placebo — DRUG
    Matching Placebo oral tablets

Study Details

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.

Key Dates

Start date
Jan 5, 2020
Status verified
Apr 2025
Primary completion
Sep 6, 2022
Completion
May 31, 2028

Study Design

Enrollment
331 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vorasidenib
    Vorasidenib 40 mg, continuous daily dosing.
  • Placebo Comparator: Matching Placebo
    Matching placebo 40 mg, continuous daily dosing.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 30 months ]

Locations (40)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
City of HopeDuarteCalifornia91010-
University of California San DiegoLa JollaCalifornia92093-
UCLA Oncology CenterLos AngelesCalifornia90095-
University of California Irvine - HospitalOrangeCalifornia92868-
University of California San FranciscoSan FranciscoCalifornia94143-
Stanford Cancer CenterStanfordCalifornia94305-
University of Colorado Hospital - Anschutz Cancer PavilionAuroraColorado80045-
Yale University, Yale Cancer CenterNew HavenConnecticut06510-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Sylvester Comprehensive Cancer Center - University of Miami Hospital and ClinicsMiamiFlorida33136-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Indiana University Medical CenterIndianapolisIndiana46202-
University of Kansas Medical CenterKansas CityKansas66160-
University of KentuckyLexingtonKentucky40536-
Maine Medical Partners NeurologyScarboroughMaine04074-
John Hopkins Cancer CenterBaltimoreMaryland21231-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Metro Minnesota Community OncologyMinneapolisMinnesota55416-
Mayo Comprehensive CancerRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Hillman Cancer CenterPittsburghPennsylvania15232-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Tennessee OncologyNashvilleTennessee37203-
Baylor University Medical CenterDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
The University of Utah, Huntsman Cancer HospitalSalt Lake CityUtah84112-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAUniversity of California San Diego· La Jolla, CAUCLA Oncology Center· Los Angeles, CAUniversity of California Irvine - Hospital· Orange, CAUniversity of California San Francisco· San Francisco, CA

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