Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
Official title: The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-07-24
Healthy Volunteers
Not specified
Conditions
Interventions
Vorasidenib
Oral therapy