← Back to Search

Vorasidenib for Glioma

Q: At how many different points around the country is this research project being conducted?

<p>Currently, this trial is being conducted in 50 different locations, which can be found in Duarte, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, Phoenix, and the other 50 sites. To limit participant burden, it is recommended you select the clinical site nearest to you.</p>

Q: Has Vorasidenib been cleared by the FDA?

<p>Vorasidenib has received a safety score of 3. This is due to the fact that this is a Phase 3 trial, meaning that initial efficacy has been proven and there is extensive safety data available.</p>

Phase 3

Waitlist Available

Research Sponsored by Agios Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC

Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug for brain cancer called vorasidenib. It is for people who have had surgery for their cancer and have an IDH1 or IDH2 mutation. The trial will compare vorasidenib to a placebo (sugar pill). Approximately 340 people will be in the trial.

Who is the study for?

This trial is for people at least 12 years old with a Grade 2 glioma brain tumor that has returned or remains after surgery. They must weigh over 40 kg, have had no other cancer treatments like chemo or radiation, and not need immediate therapy. Participants require confirmed IDH1/IDH2 mutations and measurable disease on MRI.Check my eligibility

What is being tested?

The INDIGO study tests Vorasidenib against a placebo in patients with specific recurrent brain tumors. About 340 participants will be randomly assigned to take either the drug or placebo orally once daily, without knowing which one they're receiving.See study design

What are the potential side effects?

While the trial information does not specify side effects, similar drugs can cause headaches, nausea, fatigue, joint pain, and may affect liver function. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My MRI shows measurable disease that doesn't enhance with contrast.

Select...

I am mostly active and can carry out my daily activities without help.

Select...

My cancer has a specific IDH1 or IDH2 gene mutation, confirmed by lab tests.

Select...

My brain tumor is classified as Grade 2 oligodendroglioma or astrocytoma.

Select...

I am at least 12 years old and weigh 40 kg or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS)

Secondary outcome measures

Time to Next Intervention

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VorasidenibExperimental Treatment1 Intervention

Vorasidenib 40 mg, continuous daily dosing.

Group II: Matching PlaceboPlacebo Group1 Intervention

Matching placebo 40 mg, continuous daily dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorasidenib

2023

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Agios Pharmaceuticals, Inc.Lead Sponsor

52 Previous Clinical Trials

3,875 Total Patients Enrolled

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

66,805 Total Patients Enrolled

Media Library

Matching Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04164901 — Phase 3

Brain Tumor Research Study Groups: Vorasidenib, Matching Placebo

Brain Tumor Clinical Trial 2023: Matching Placebo Highlights & Side Effects. Trial Name: NCT04164901 — Phase 3

Matching Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164901 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different points around the country is this research project being conducted?

"Currently, this trial is being conducted in 50 different locations, which can be found in Duarte, New york, Phoenix, and the other 50 sites. To limit participant burden, it is recommended you select the clinical site nearest to you."

Answered by AI

Has Vorasidenib been cleared by the FDA?

"Vorasidenib has received a safety score of 3. This is due to the fact that this is a Phase 3 trial, meaning that initial efficacy has been proven and there is extensive safety data available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04164901.