Safety and Efficacy Study in Recurrent Grade IV Glioma
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This multi-site, Phase 1/2a clinical trial is an open-label study to identify the safety,
pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for
the treatment of patients with radiographically-confirmed progression of Grade IV glioma or
recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and
Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the
maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1.
There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be
self-administered four times daily for a 28-day treatment cycle up to six cycles until
disease progression or death, whichever occurs first. At the completion of cycle six,
patients will be given the option to continue receiving compassionate use treatment
cycles.This is the first nasal administration in the US, after prior oral studies with
perillyl alcohol proved ineffective. Nasal administration of perillyl alcohol is on-going in
Brazil