Vorasidenib Expanded Access Program

NCT05592743 | Unknown

• 1 other identifier: VORA-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. For participants in Japan, DIM-95032-001-JPN will provide access to vorasidenib for Japanese participants aged 12 years and older with IDH1- or IDH2-mutant diffuse glioma who have undergone surgery as their only treatment and have no immediate need for radiotherapy and/or chemotherapy. Participants will receive vorasidenib once daily as long as they continue to see a benefit, do not experience unacceptable reactions, and vorasidenib is not commercially available by prescription. Enrollment will continue until vorasidenib is commercially available in Japan or until the study closes. Participants will transition off the study within approximately 3 months after vorasidenib becomes commercially available by prescription with local reimbursement (price listing) in Japan. A final safety follow-up visit is conducted 30 days after the last dose of treatment on the study.

Conditions

Diffuse Glioma; 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; Diffuse Glioma With IDH1 or IDH2 Mutations

Keywords

Vorasidenib; AG-881; S95032; Glioma; Oligodendroglioma; Astrocytoma; IDH-1; IDH-2

Interventions

Vorasidenib DRUG

Oral therapy

Also known as: AG-881, S95032

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a creatinine clearance (CrCl) ≥ 40 mL/min
• Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician
• Be able to understand and willing to sign informed consent/assent as determined by local requirements

You may not qualify if:

• 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.
• Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
• Are participating in another investigational or interventional clinical trial
• Have had any prior anticancer therapy other than surgery for treatment of glioma including systemic chemotherapy, radiotherapy, IDH inhibitors, and other anticancer therapies (investigational agents)
• Are pregnant or breast feeding
• Are men or women who will not agree to use highly effective forms of contraception during the trial
• Have Grade 4 astrocytoma
• Are taking strong CYP1A2 inhibitors like fluvoxamine maleate (Luvox, Depromel), etc

Sponsors & Collaborators

• Servier: lead
• Servier Pharmaceuticals, LLC: collaborator

MeSH Terms

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; Oligodendroglioma; Astrocytoma

Interventions

vorasidenib

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Dewey, MD

  Servier Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 25, 2022
• Last Updated: July 24, 2026

Record last verified: 2026-07