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Vorasidenib Expanded Access Program

NCT05592743 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2026-07-24

No results posted yet for this study

Summary

This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.

For participants in Japan, DIM-95032-001-JPN will provide access to vorasidenib for Japanese participants aged 12 years and older with IDH1- or IDH2-mutant diffuse glioma who have undergone surgery as their only treatment and have no immediate need for radiotherapy and/or chemotherapy. Participants will receive vorasidenib once daily as long as they continue to see a benefit, do not experience unacceptable reactions, and vorasidenib is not commercially available by prescription. Enrollment will continue until vorasidenib is commercially available in Japan or until the study closes. Participants will transition off the study within approximately 3 months after vorasidenib becomes commercially available by prescription with local reimbursement (price listing) in Japan. A final safety follow-up visit is conducted 30 days after the last dose of treatment on the study.

Conditions

  • Glioma
  • Recurrence
  • Disease Attributes
  • Pathologic Processes
  • Neoplasms, Neuroepithelial
  • Neuroectodermal Tumors
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms by Histologic Type
  • Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Neoplasms, Nerve Tissue
  • Diffuse Glioma
  • Diffuse Glioma With IDH1 or IDH2 Mutations

Interventions

DRUG

Vorasidenib

Oral therapy

Sponsors & Collaborators

  • Servier Pharmaceuticals, LLC

    collaborator UNKNOWN

  • Servier

    lead INDUSTRY

Principal Investigators

  • Jonathan Dewey, MD · Servier Pharmaceuticals, LLC

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592743 on ClinicalTrials.gov