Vorasidenib Expanded Access Program

Sponsor
Servier
Study ID
NCT05592743
Status
Approved For Marketing

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 25, 2022
Status verified
Jul 2026

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