Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioma

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Vorasidenib 40 mg, continuous daily dosing.

Matching placebo 40 mg, continuous daily dosing.

Vorasidenib

Matching Placebo

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.

Participants randomized in a 1:1 allocation (vorasidenib vs Placebo)

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

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

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

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.

Institut de Recherches Internationales Servier

All AEs and SAEs were to be recorded starting at the first dose of IMP through 28 days after the last dose of IMP. After the 28-day follow-up period, only SAEs that were considered to be related to IMP were reported in the safety database.

Vorasidenib 40 mg, continuous daily dosing.

Vorasidenib: Vorasidenib oral film-coated tablets

Matching placebo 40 mg, continuous daily dosing.

Matching Placebo: Matching Placebo oral tablets

Total

Age, Continuous

Participant Age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

Canada

Netherlands

United States

Italy

United Kingdom

Israel

France

Switzerland

Germany

Spain

Region of Enrollment

BMI (kg/m^2)

Clinical Studies Department

Progression-Free Survival (PFS)

Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets

Time to Next Intervention

Overall Study

Spots Global Cancer Trial Database for residual glioma