Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
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.
| Condition(s) | Glioblastoma Multiforme |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 fi |
| Who can participate | 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 must have failed previous radiation treatment or combined treatment with temozolomide and radiation. * If progression of disease occurs within 90 days of conformal radiation, the progression/recurrence m |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Neonc Technologies, Inc. |
| Locations | Los Angeles, California, United States; Santa Monica, California, United States; Augusta, Georgia, United States; New Orleans, Louisiana, United States; Summit, New Jersey, United States; New York, New York, United States (+6 more sites) |
| Start date | 2017-08-01 |
| NCT ID | NCT02704858 |
| Official listing | https://clinicaltrials.gov/study/NCT02704858 |