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Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

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Servier Protocol Code: S095032-211 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT06478212 EU Trial (CTIS) Number: 2024-513738-39-00

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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 32 locations

Study description

This study is needed to test a drug called vorasidenib in combination with another drug, temozolomide (TMZ), in participants with glioma carrying an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation (change in a specific gene). Glioma is a type of cancer that starts in the glial cells in the brain or spinal cord.

In some types of cancers, abnormal forms of the IDH1 or IDH2 proteins are present in the cancer cells due to changes called mutations. When these proteins are present in abnormal forms, they produce too much 2-hydroxyglutarate (2-HG). This impairs normal cell functioning and may cause cells to become cancer cells.

Participants will be treated with a combination of vorasidenib and TMZ. TMZ is an approved medicine for the treatment of glioma. Vorasidenib is a drug that blocks the activity of abnormal IDH1 and IDH2 proteins and thus may reduce 2-HG levels in cancer cells. Vorasidenib is approved in some regions for the treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

The main goals of this study are:

  • To assess if the combination of vorasidenib and TMZ is safe, tolerable, and effective in participants with glioma carrying an IDH1 or IDH2 mutation.
  • To find the dose of vorasidenib and TMZ that is both safe and effective (the recommended dose) for the treatment of patients with glioma.
Official title: A Phase 1b/2, Multicenter Study of Vorasidenib in Combination With Temozolomide (TMZ) in Participants With IDH1- or IDH2-mutant Glioma
Protocol
English (USA)
Conditions
IDH1-mutant Glioma IDH2-mutant Glioma
Interventions / Treatments
  • Vorasidenib
  • Temozolomide (TMZ)
Other study id numbers
  • S095032-211

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 years old.
  • Have glioma with an IDH1 or IDH2 mutation.
  • Have normal kidney, liver, and bone marrow (the spongy tissue inside bones that makes blood cells) function.

Participants cannot take part in the study if:

  • They have previously received a drug that blocks IDH1 or IDH2.
  • They have or have had another type of cancer at the same time as their glioma.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Phase 1b: Vorasidenib and Temozolomide (TMZ)

This part of the study tests if the combination of vorasidenib with TMZ is safe and well-tolerated and to find the recommended dose of this combination.

Intervention / Treatment
Drug: Vorasidenib

Participants receive vorasidenib tablet(s) at a starting dose of 40 mg to be taken by mouth every day of each 28-day cycle.

Drug: Temozolomide (TMZ)

Participants receive TMZ capsules by mouth once a day at a dose of 150 mg/m² for the first 5 consecutive days of Cycle 1, with no TMZ intake for the remaining 23 days of the cycle. For Cycles 2 to 12, the TMZ dose may increase to 200 mg/m², following the same 5-day regimen. Participants can receive TMZ for up to 12 cycles.

Participant Group / Arm
Experimental: Phase 2: Vorasidenib recommended combination dose (RCD) and Temozolomide (TMZ)

This part of the study tests if the recommended dose found in Phase 1b is safe and effective in a larger group of participants.

Intervention / Treatment
Drug: Vorasidenib

Participants receive the recommended dose of vorasidenib in combination with TMZ.

Drug: Temozolomide (TMZ)

Participants receive the recommended dose of vorasidenib in combination with TMZ.

Keywords

Provided by Servier
IDH-mutant glioma IDH mutation vorasidenib S95032 Phase 1/2 pediatric