Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NEO100 · 2 trials · 9 indications
Progression free survival
Assess the safety and tolerability of increasing dose levels of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs
| Arm | Type | Description |
|---|---|---|
| Patients with high-grade meningioma | EXPERIMENTAL | 30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma |
| Phase 1b safety, dose finding, brain-tumor delivery, and pharmacokinetics of IN NEO100 | EXPERIMENTAL | Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid). The study will use a modified Fibonacci dose titration design, followed by a standard dose escalation design. * Cohort 1: 192 mg NEO100, QID on a 28-day cycle * Cohort 2: 288 mg NEO100, QID on a 28-day cycle * Cohort 3: 384 mg NEO100, TID on a 28-day cycle; * Cohort 4 (ceiling dose): 576 mg NEO100, BID on a 28-day cycle. Patients undergoing surgical or needle biopsy (only when clinically indicated) will receive a minimum of four days IN NEO100 treatment prior to the procedure. |
| Name | Type | Description |
|---|---|---|
| NEO100 | DRUG | NEO100 is a purified form of perillyl alcohol. |
Inclusion Criteria Patient must: 1. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed. 1. Residual disease is defined as residual measurab...