Study on Vorasidenib and Temozolomide for IDH-mutant Glioma

Sponsor: Institut de Recherches Internationales Servier

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06478212

Provider View

This clinical trial is testing the safety and effectiveness of combining the drugs vorasidenib and temozolomide (TMZ) to treat glioma with IDH mutations. The study will first determine the best dose and then evaluate how well the treatment works.

Patient Parameters

Program Overview

The study aims to find out if the combination of vorasidenib and temozolomide (TMZ) is safe and effective for treating glioma with IDH mutations. Initially, the study will focus on finding the right dose of vorasidenib to use with TMZ. After that, the study will assess how well this combination works in treating the cancer. Participants will have regular study visits, including check-ups and tests, to monitor their health and the treatment's effects. After treatment ends, there will be a follow-up visit and ongoing check-ins every three months to track survival.

Eligibility Criteria

Inclusion Criteria

  • Be 12 years or older and weigh at least 40 kg.
  • Have a confirmed IDH1 or IDH2 mutation in the tumor.
  • Have good kidney function.
  • Have healthy bone marrow, with specific blood cell counts.
  • Be expected to live for at least 3 more months.
  • Have a performance status score of 70 or higher, indicating the ability to carry out daily activities.
  • If taking steroids for glioma, the dose must be stable or decreasing.
  • Women who can have children must test negative for pregnancy before starting treatment.

Phase 1b ONLY:

  • Have a confirmed diagnosis of Grade 2, 3, or 4 IDH-mutant glioma.
  • Be suitable to receive TMZ after radiation therapy or for the first recurrence of the disease.
  • Have good liver function, with specific blood test results.

Phase 2 ONLY:

  • Have a confirmed diagnosis of Grade 4 astrocytoma with IDH mutation.
  • Have received standard radiation therapy with TMZ before joining the study.
  • Have good liver function, with specific blood test results.

Exclusion Criteria

  • Cannot swallow pills.
  • Are pregnant or breastfeeding.
  • Are in another treatment study at the same time.
  • Have cancer that has spread to the brain's lining.
  • Have a bleeding disorder.
  • Have had previous treatment with an IDH inhibitor or certain other drugs.
  • Have another active cancer, except for certain skin cancers or treated in situ cancers.
  • Have a genetic condition affecting DNA repair.
  • Are allergic to vorasidenib or TMZ.
  • Have serious heart problems or a high risk of heart rhythm issues.
  • Have active hepatitis B, hepatitis C, or HIV, unless well-controlled.

Phase 1b ONLY:

  • Have worsening disease during or after radiation therapy.
  • Have had more than one previous treatment for glioma.
  • Have had severe liver or blood-related side effects from previous treatments.

Phase 2 ONLY:

  • Have received other treatments for glioma besides surgery and standard radiation with TMZ.
  • Have worsening disease during or after standard treatment with radiation and TMZ.
  • Have had severe blood or liver-related side effects from previous treatments.

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