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Vorasidenib Expanded Access Program

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ClinicalTrials.gov Identifier: NCT05592743
Expanded Access Status : Available
First Posted : October 25, 2022
Last Update Posted : April 26, 2024
Sponsor:
Collaborator:
Servier Pharmaceuticals, LLC
Information provided by (Responsible Party):
Servier

Study Description
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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
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
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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
Official Title: The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Vorasidenib
    Oral therapy
    Other Name: AG-881, S95032
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Male and females; ages ≥ 12 years old.
  2. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis.
  3. At least 1 prior surgery for glioma (including biopsy).

  4. Adequate bone marrow function as evidenced by:

    • Absolute neutrophil count ≥ 1.5 X 109/L
    • Hemoglobin ≥ 9 g/dL
    • Platelets ≥ 100 X 109/L

  5. Adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN)
    • Aspartate aminotransferase and alanine aminotransferase: at or below the ULN
    • Alkaline phosphatase ≤ 2.5 X ULN

  6. Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min

    Exclusion criteria:

  7. Patient is eligible for a clinical trial with vorasidenib.
  8. Patients who are enrolled in a Servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment.
  9. Pregnant or breastfeeding.
  10. Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05592743


Contacts
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Contact: Servier Pharmaceuticals LLC 1-203-441-7938 (ext. 125) expandedaccess@servier.com

Sponsors and Collaborators
Servier
Servier Pharmaceuticals, LLC
Investigators
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Study Director: Jonathan Dewey, MD Servier Pharmaceuticals, LLC
More Information
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Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT05592743    
Other Study ID Numbers: VORA-EAP
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Keywords provided by Servier:
Vorasidenib
AG-881
S95032
Glioma
 Oligodendroglioma
Astrocytoma
IDH-1
IDH-2
Additional relevant MeSH terms:
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Neoplasms
Glioma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
 Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Recurrence
Pathologic Processes
Disease Attributes