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NEO100 and High-Grade Meningioma

StatusRecruiting
PhasePhase 2
Started2022-07-01
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 9 times since 2021-08-25; most recent filed 2026-07-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-15
Amendment Study Status, Contacts/Locations v9
2026-02-27
Amendment Study Status, Contacts/Locations v8
2026-01-14
Amendment Study Status, Contacts/Locations v7
2026-01-13
Amendment Study Status, Eligibility, Contacts/Locations v6
2025-12-18
Amendment Study Identification, Study Status, Oversight, Contacts/Locations v5
2024-10-10
Amendment Study Identification, Study Status, Oversight, Study Description, Study Design, Eligibility, Contacts/Locations v4
2024-02-14
Amendment Study Status, Eligibility v3
2023-03-21
Amendment Study Status, Eligibility, Contacts/Locations v2
2022-09-23
Amendment Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
2021-08-25
Original filing
Trial Details
NCT Number NCT05023018
Lead Sponsor Neonc Technologies, Inc.
Conditions Residual, Progressive or Recurrent Grade II or III Meningioma
Enrollment 30 participants
Start Date 2022-07-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-15