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.

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

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

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.

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: November 5, 2024

Record last verified: 2024-11