Vorasidenib Expanded Access Program

November 1, 2024 updated by: Servier

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

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

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier

Collaborators

Servier Pharmaceuticals, LLC

Investigators

  • Study Director: Jonathan Dewey, MD, Servier Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VORA-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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