Vorasidenib Expanded Access Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Drug: Vorasidenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females; ages ≥ 12 years old. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis. At least 1 prior surgery for glioma (including biopsy). Adequate bone marrow function as evidenced by: Absolute neutrophil count ≥ 1.5 X 109/L Hemoglobin ≥ 9 g/dL Platelets ≥ 100 X 109/L 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 Adequate renal function as evidenced by: Serum Creatinine ≤ 2 X ULN, or Creatinine Clearance ≥ 40 mL/min Exclusion criteria: Patient is eligible for a clinical trial with vorasidenib. 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. Pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vorasidenib|Oral therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vorasidenib, AG-881, S95032, Glioma, Oligodendroglioma, Astrocytoma, IDH-1, IDH-2