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

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

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Servier Protocol Code: AG881-C-004 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04164901 EudraCT Number: 2019‐002481‐13 EU Trial (CTIS) Number: 2024-512961-15-00

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 84 locations

Study description

The Indigo study is looking into a new treatment for a type of brain tumour called Grade 2 glioma. These tumours may come back or continue to grow, even after surgery. Researchers have discovered that many of these tumours have mutations (changes) in specific genes called IDH1 or IDH2. These mutations result in abnormal IDH proteins in the cancer cells that can help the tumour. Vorasidenib (also called AG-881) is a drug that is designed to block the abnormal IDH1 and IDH2 proteins in cancer cells. The aim of the study is to see if vorasidenib is safe and effective in stopping these tumours from growing. This research is important because, currently, there are limited treatment options for patients with this type of tumour who have already had surgery.

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
Protocol
English (USA)
Conditions
Grade 2 Glioma Residual Glioma Recurrent Glioma
Interventions / Treatments
  • Vorasidenib
  • Matching Placebo
Other study id numbers
  • AG881-C-004

Eligibility Criteria

Eligible age for the study

12 years and older (Child, Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part of the study, participants have to:

  • be at least 12 years old (or 18 years old in Germany) and weigh at least 40 kg.
  • have a specific type of brain tumor called oligodendroglioma or astrocytoma.
  • have had surgery to remove the tumour at least one year ago but not more than five years ago.
  • have a specific gene mutation (IDH1 or IDH2) in their tumour, confirmed through special tests.
  • have a cancer that can be measured using MRI scans and doesn’t show extra growth.
  • be generally healthy with well-functioning bone marrow (the spongy tissue inside bones where blood cells are made), liver and kidneys.

Participants cannot take part in the study if:

  • they have received any cancer treatment other than surgery, like chemotherapy (treatment with medicines) or radiotherapy (treatment with radiation).
  • they have an immediate need for chemotherapy or radiotherapy.
  • their condition is assessed as high-risk by the doctor.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Vorasidenib

Participants receive vorasidenib 40 milligrams (mg) as tablets, to be taken by mouth once a day during time periods called “cycles”. One cycle lasts 28 days.

Intervention / Treatment
Drug: Vorasidenib
Participant Group / Arm
Placebo Comparator: Matching Placebo

Participants receive placebo as tablets, to be taken by mouth once a day during time periods called “cycles”. One cycle lasts 28 days.

Intervention / Treatment
Drug: Matching Placebo

The placebo looks like vorasidenib but does not have any medicine in it.

Keywords

Provided by Servier
AG-881
Additional Relevant MeSH Terms Glioma
Glioma