NEO100 and High-Grade Meningioma

Conditions

• Residual, Progressive or Recurrent Grade II or III Meningioma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NEO100 — DRUG
  NEO100 is a purified form of perillyl alcohol.

Study Details

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.

Key Dates

Start date

Jul 1, 2022

Status verified

Jan 2026

Primary completion

Dec 30, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients with high-grade meningioma
  30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma

Primary Outcome Measure

Progression free survival as six months (PFS6). [ Time Frame: 6 months ]

Central Contacts

• Chris Beardmore
  224 218 2408
  [email protected]
• Chloe Richmond
  224 218 2408
  [email protected]

Locations (3)

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