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Vorasidenib Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05592743
Expanded Access Status : Available
First Posted : October 25, 2022
Last Update Posted : April 26, 2024
Sponsor:
Collaborator:
Servier Pharmaceuticals, LLC
Information provided by (Responsible Party):
Servier

Tracking Information
First Submitted Date October 19, 2022
First Posted Date October 25, 2022
Last Update Posted Date April 26, 2024
 
Descriptive Information
Brief Title Vorasidenib Expanded Access Program
Official Title The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma
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.
Study Type Expanded Access
Expanded Access Type Individual Patients, Treatment IND/Protocol
Condition
  • 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 Drug: Vorasidenib
Oral therapy
Other Name: AG-881, S95032
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Contacts
Contact: Servier Pharmaceuticals LLC 1-203-441-7938 (ext. 125) expandedaccess@servier.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05592743
Other Study ID Numbers VORA-EAP
Current Responsible Party Servier
Original Responsible Party Same as current
Current Study Sponsor Servier
Original Study Sponsor Same as current
Collaborators Servier Pharmaceuticals, LLC
Investigators
Study Director: Jonathan Dewey, MD Servier Pharmaceuticals, LLC
PRS Account Servier
Verification Date April 2024