- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592743
Vorasidenib Expanded Access Program
The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Expanded Access Type
- Individual Patients
- Treatment IND/Protocol
Contacts and Locations
Study Contact
- Name: Servier Pharmaceuticals LLC
- Phone Number: 1-203-441-7938 (ext. 125)
- Email: expandedaccess@servier.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 a creatinine clearance (CrCl) ≥ 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.
- Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jonathan Dewey, MD, Servier Pharmaceuticals, LLC
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VORA-EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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