An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation
Neonc Technologies, Inc.
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 cycles until disease progression, death or patient withdraw from study for any reason, whichever occurs first. Version 10 of the protocol changed the inclusion criteria for Phase 2a to limit inclusion to those patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. Prior to the protocol amendment, 4 patients were enrolled who were IDH1 wild-type. Therefore, an additional 28 patients will be recruited for a total of 32 patients enrolled into Phase 2a of this study to have 35 evaluable cases. Version 12 of the protocol expanded the inclusion criteria for Phase 2a to include those patients with progressive or recurrent Grade III Astrocytoma expressing IDH1 mutations. Review of the literature specific to these patients found the same expected time to progression and death. As a result, the number of patients to enroll remains 32 to have 35 evaluable cases.
Description
Malignant glioma, particularly glioblastoma multiforme (GBM, WHO grade IV astrocytic glioma) accounts for over half of all gliomas, which in turn account for 80% of all malignant brain and CNS tumors. In European and North American countries, the incidence rate is approximately four to five new cases per 100,000 people per year. Most patients with glioblastoma are faced with a dismal prognosis. Advances in neurosurgery, radiation, and chemotherapy during the past decade have provided only small improvements in clinical outcome, with a 5-year survival rate remaining at less than 10%.The first-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria To be eligible to participate in the study, a patient must meet all of the following inclusion criteria: * Patient must have radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (confirmed by biopsy) and subcortical glioma. * Patient must have radiographically-confirmed progression of, recurrent, primary or secondary Grade III astrocytoma. * All patients must be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent. * Patient m…
Interventions
- DrugPerillyl alcohol
Intranasal administration
Locations (12)
- University of Southern CaliforniaLos Angeles, California
- Saint John Cancer InstituteSanta Monica, California
- Georgia Cancer Center (Augusta University)Augusta, Georgia
- Ochsner HealthNew Orleans, Louisiana
- Atlantic Health (Overlook Medical Center)Summit, New Jersey
- Northwell HealthNew York, New York