Individual Patient Expanded Access for treatment of IDH-1 or IDH2-mutated glioma.

This is a 28 y/o F, 49 kg, with diagnosis of IDH1 mutated grade II oligodendroglioma s/p subtotal resection of right frontal lobe. New data has shown to have PFS benefit while avoiding chemoRT adverse effects via INDIGO trial.

Vorasidenib will be initiated at a dose of 40mg QD, by oral administration. The patient will be monitored for tolerance and adverse events every two weeks for the first 2 months, and then monthly thereafter. Labs to be monitored include liver function tests (AST, ALT, T. Bili), chemistry, and hematology. AEs and lab abnormalities will be managed using the guidance provided by Servier in the Physician Treatment Guideline, Tables 1 and 2. For any AE the dose of vorasidenib may be adjusted based on clinical judgment. If downward dose adjustment is clinically indicated, the first dose reduction level will be from 40mg QD to 20mg QD. If necessary, a second dose reduction will be made reducing the vorasidenib dose from 20mg QD to 10mg QD. Provided the patient is deriving clinical benefit as assessed by the Sponsor-Investigator, vorasidenib will continue to be supplied until vorasidenib is available by prescription or the patient shows progression or no longer requires vorasidenib.

For further information about clinical trials, please contact us at 732-235-7356.