Vorasidenib for Glioma
Recruiting at 90 trial locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Agios Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial is testing an oral medication called vorasidenib in patients with a specific type of brain tumor that has a genetic mutation. The drug aims to block proteins that help the tumor grow, potentially slowing or stopping its growth.
Research Team
Eligibility Criteria
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.Inclusion Criteria
I had surgery for glioma between 1 and 5 years ago and haven't had any other cancer treatments.
My MRI shows measurable disease that doesn't enhance with contrast.
I am mostly active and can carry out my daily activities without help.
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Exclusion Criteria
I have only had surgery for my glioma, no other cancer treatments.
My brain tumor is considered high-risk, possibly affecting my brainstem or causing significant symptoms or uncontrolled seizures despite treatment.
Treatment Details
Interventions
- Matching Placebo (Chemotherapy)
- Vorasidenib (IDH Inhibitor)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Agios Pharmaceuticals, Inc.
Lead Sponsor
Trials
55
Recruited
4,200+
Institut de Recherches Internationales Servier
Lead Sponsor
Trials
91
Recruited
67,100+
Olivier Laureau
Institut de Recherches Internationales Servier
Chief Executive Officer since 2014
Degree in Law from Panthéon-Assas University, Paris
Dr. Arnaud Lallouette
Institut de Recherches Internationales Servier
Chief Medical Officer since 2021
MD from Lille 2 University of Science and Technology