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History of Changes for Study: NCT05592743
Vorasidenib Expanded Access Program
Latest version (submitted April 24, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 19, 2022 None (earliest Version on record)
2 June 8, 2023 Contacts/Locations, Eligibility and Study Status
3 October 13, 2023 Study Status and Eligibility
4 October 18, 2023 Eligibility and Study Status
5 December 21, 2023 Study Status and Eligibility
6 April 24, 2024 Study Status, Eligibility, Study Design and Study Identification
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Study NCT05592743
Submitted Date:  October 19, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: VORA-EAP-01
Brief Title: Vorasidenib Expanded Access Program
Official Title: The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2022
Expanded Access Status: Available
Open or close this module Sponsor/Collaborators
Sponsor: Servier
Responsible Party: Sponsor
Collaborators: Servier Pharmaceuticals, LLC
Open or close this module Oversight
Open or close this module 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.
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.
Open or close this module Conditions
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
Keywords: Vorasidenib
AG-881
S95032
Glioma
Oligodendroglioma
Astrocytoma
IDH-1
IDH-2
Open or close this module Study Design
Study Type: Expanded Access
Individual Patients
Open or close this module Interventions
Interventions: Drug: Vorasidenib
Other Names:
  • AG-881, S95032
Oral therapy
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Servier Pharmaceuticals LLC
Telephone: 1-888-441-7938 (ext. 125)
Email: expandedaccess@servier.com
Study Officials: Jonathan Dewey, MD
Study Director
Servier Pharmaceuticals, LLC
Locations:
Open or close this module References
Citations:
Links:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services