Vorasidenib Expanded Access Program

NCT ID: NCT05592743

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

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.

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

Interventions

Vorasidenib

Oral therapy

Intervention Type: DRUG

Other Intervention Names

AG-881, S95032

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier Pharmaceuticals, LLC

UNKNOWN

Sponsor Role: collaborator

Servier

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Dewey, MD

Role: STUDY_DIRECTOR

Servier Pharmaceuticals, LLC

Other Identifiers

VORA-EAP

Identifier Type: -

Identifier Source: org_study_id