Vorasidenib Expanded Access Program

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Expanded Access
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05592743
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Servier
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jonathan Dewey, MD
Principal Investigator Affiliation	Servier Pharmaceuticals, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Available
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Servier Pharmaceuticals LLC

[email protected]

1-203-441-7938 (ext. 125)

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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