Trials / Approved For Marketing
Approved For MarketingNCT05592743
Vorasidenib Expanded Access Program
The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Servier · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
Summary
This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
Detailed description
This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib. Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated. Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vorasidenib | Oral therapy |
Timeline
- First posted
- 2022-10-25
- Last updated
- 2024-11-05
Source: ClinicalTrials.gov record NCT05592743. Inclusion in this directory is not an endorsement.