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Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

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Servier Protocol Code: CL3-95032-016 Sponsor: Servier Clinicaltrials.gov Identifier: NCT06780930

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How to participate to the 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 don’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 17 locations

Study description

This study is looking into a new treatment for Asian patients with a type of brain tumour called Grade 2 glioma that has specific gene changes called IDH1 or IDH2 mutations. Researchers have discovered that IDH1 or IDH2 mutations result in abnormal IDH proteins in the cancer cells, which can help the tumour grow. The study includes patients with tumours that may come back after surgery (called recurrent) or continue to grow, even after surgery (called residual).

The study drug vorasidenib (also called AG-881) is designed to block these abnormal IDH1 and IDH2 proteins in cancer cells. This research is important because treatment options are limited for patients with this type of tumour who have already had surgery.

This study has 2 parts. The first part assesses the safety of vorasidenib. The second part measures how well vorasidenib works compared to a placebo. A placebo looks like the study drug but contains no medicine.

The main goal of the study is to test how well vorasidenib works in Asian participants with recurrent or residual Grade 2 glioma with an IDH1 or IDH2 mutation.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
Conditions
Residual or Recurrent Grade 2 IDH Mutant Glioma
Interventions / Treatments
  • Vorasidenib
  • Placebo
Other study id numbers
  • CL3-95032-016

Eligibility Criteria

Eligible age for the study

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

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be at least 12 or 18 years old (depending on which part of the study they participate in) and weigh at least 40 kg.
  • Have a type of brain tumour called oligodendroglioma or astrocytoma that is classified as Grade 2.
  • Have a specific gene mutation (IDH1 or IDH2) in their tumour.
  • Have had surgery to remove the tumour at least one year ago but no more than five years ago.
  • Have not had other previous anticancer treatment with medicines (chemotherapy) or radiotherapy, and do not need immediate chemotherapy or radiotherapy.

 

 

 

 

 

 

Participants cannot take part in the study if:

  • They have had any treatments for glioma other than surgery.
  • Their tumour is considered high-risk by the doctor.
  • They have another active cancer.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Vorasidenib (part 1)

All participants in part 1 receive open-lable vorasidenib. Open-label means both the study doctors and the participants know which treatment is given.

Intervention / Treatment
Drug: Vorasidenib

Participants take vorasidenib by mouth once daily, in time periods called cycles. Each cycle lasts 28 days.

Participant Group / Arm
Experimental: Vorasidenib (part 2)

Participants in part 2 are randomly assigned to receive either vorasidenib or placebo.

Intervention / Treatment
Drug: Vorasidenib

Participants take vorasidenib by mouth once daily, in time periods called cycles. Each cycle lasts 28 days.

Participant Group / Arm
Placebo Comparator: Placebo (part 2)

Participants in part 2 are randomly assigned to receive either vorasidenib or placebo.

Intervention / Treatment
Drug: Placebo

Participants take placebo by mouth once daily, in time periods called cycles. Each cycle lasts 28 days.