Vorasidenib Expanded Access Program

Sponsor

Servier (Industry)

Overall Status

Available

CT.gov ID

NCT05592743

Collaborator

Servier Pharmaceuticals, LLC (Other)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Vorasidenib

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.

Study Design

Study Type:

Expanded Access

Official Title:

The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Age ≥ 12 years old and weighing at least 40 kg.
Have Grade 2 or 3 oligodendroglioma or astrocytoma per WHO 2016 or 2021 criteria. Patients with Grade 4 astrocytomas may be considered on a case-by-case basis.
Have confirmed IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis
Have at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection)
Have received chemotherapy and/or radiotherapy.
Have disease recurrence or progression. Patients with stable residual disease after standard of care therapy who, in the opinion of the investigator, are likely to gain benefit from treatment may be considered on a case-by-case basis.
Have adequate bone marrow function.
Have adequate hepatic function.
Have adequate renal function.
Have adequate cardiac function.

Exclusion Criteria:

Patient is eligible for ivosidenib Patient Assistance Program.
Patient is eligible for a clinical trial with vorasidenib or ivosidenib.
Prior treatment with IDH inhibitor, unless there is isoform switching confirmed by tissue-based diagnosis.
Have a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with bundle branch block and prolonged QTcF may be eligible at the discretion of Servier Pharmaceuticals and the investigator.
Are pregnant or breastfeeding.