Vorasidenib Access Program for Patients with IDH1 or IDH2 Mutated Glioma

Sponsor: Servier

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05592743

Provider View

This program provides access to the drug vorasidenib for patients aged 12 and older with specific types of brain tumors (gliomas) that have certain genetic mutations, and who cannot join other clinical trials for this treatment.

Patient Parameters

Program Overview

The purpose of this program is to offer the drug vorasidenib to patients with gliomas that have IDH1 or IDH2 mutations, who are not eligible for other clinical trials involving this drug. The program aims to help patients who might benefit from vorasidenib, as determined by their doctor. Patients will have regular health checks, including blood tests, every two weeks for the first two months, and then monthly. Treatment will continue as long as the doctor believes it is beneficial, until the drug becomes available by prescription, or until the program ends.

Description

This program allows patients with certain brain tumors (gliomas) that have IDH1 or IDH2 mutations to access the drug vorasidenib if they cannot participate in other clinical trials for this medication. Patients will undergo regular health assessments, including checking vital signs and blood tests, every two weeks initially, then monthly. The treatment will continue as long as it is deemed beneficial by the doctor, until the drug is available by prescription, or until the program concludes. Doctors can request to enroll individual patients in this program on a case-by-case basis.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 12 years or older.
  • Have a type of brain tumor called oligodendroglioma or astrocytoma with IDH1 or IDH2 gene mutation confirmed by a tissue test.
  • Have had at least one surgery for the brain tumor, including a biopsy.
  • Have good bone marrow function, shown by specific blood test results:
    • Neutrophil count of at least 1.5 x 10^9/L
    • Hemoglobin level of at least 9 g/dL
    • Platelet count of at least 100 x 10^9/L
  • Have good liver function, shown by specific blood test results:
    • Total bilirubin level at or below 1.5 times the normal limit
    • Liver enzymes (AST and ALT) at or below normal limits
    • Alkaline phosphatase level at or below 2.5 times the normal limit
  • Have good kidney function, shown by a creatinine clearance of at least 40 mL/min

Exclusion Criteria

  • Eligible for a clinical trial with vorasidenib.
  • Enrolled in a Servier-sponsored clinical trial and have completed all requirements, unless continuing to benefit from vorasidenib without meeting criteria for stopping treatment.
  • Pregnant or breastfeeding.
  • Require or cannot avoid using strong inhibitors of CYP1A2 (such as ciprofloxacin and fluvoxamine). Consider alternative treatments that do not strongly inhibit CYP1A2.

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