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NEO100 and High-Grade Meningioma

NCT05023018 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-02

No results posted yet for this study

Summary

This multi-site, Phase 2 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 residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.

Conditions

  • Residual, Progressive or Recurrent Grade II or III Meningioma

Interventions

DRUG

NEO100

NEO100 is a purified form of perillyl alcohol.

Sponsors & Collaborators

  • Neonc Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Chen, MD, PhD · NeOnc Technologies

  • Josh Neman · NeOnc Technologies Holdings, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-12-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023018 on ClinicalTrials.gov