An Open-Label, Phase 2 Study of NEO100 in Participants with Residual, Progressive or Recurrent High-Grade Meningioma

Who is this study for? Patients with residual, progressive or recurrent high-grade meningioma
What treatments are being studied? NEO100
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Patient must be ≥ 12 years of age.

• Patient must have an ECOG performance status of 0-2 or KPS ≥ 60.

• Patient must have an expected survival of at least three months.

• Patient must be willing to provide blood sample for pharmacokinetic study (to assess proper administration of NEO100).

⁃ Patient must have adequate organ and marrow function as defined below:

⁃ White blood cell (WBC) ≥2000/microliter

⁃ Absolute neutrophil count (ANC) ≥ 1,500/microliter

⁃ Platelets ≥ 100,000/microliter

⁃ Hemoglobin ≥9 gm/dl

⁃ AST (SGOT)/ALT (SPGT) ≤ 2.5 × laboratory upper limit of normal (ULN)

⁃ Serum creatinine ≤ 1.5 x laboratory upper limit of normal (ULN) or

⁃ Creatinine clearance (meas or calc) ≥60mL/min for participants with creatinine levels \>1.5x laboratory upper limit of normal (ULN)

⁃ Total serum bilirubin ≤ 1.5 x laboratory upper limit of normal (ULN) except participants with Gilbert's Syndrome who can have a total serum bilirubin of \<5 x laboratory upper limit of normal (ULN)

⁃ MRI (or CT if MRI contraindicated) within 14 days prior to start of study drug. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening scan and the start of treatment, a new baseline scan is required.

⁃ Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first administration of study drug, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

⁃ A female of child-bearing potential is any woman (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

⁃ i. Has not undergone a hysterectomy or bilateral oophorectomy; or ii. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

⁃ A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to initiating study drug.

⁃ A serum pregnancy test will be repeated immediately if pregnancy is suspected.

⁃ Women must not be breastfeeding.

⁃ Patient must have the ability to understand, and the willingness comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study as confirmed by signing a written informed consent document.

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
Contact Information
Primary
Chris Beardmore
chris@anovaevidence.com
224 218 2408
Backup
Chloe Richmond
chloe@anovaevidence.com
224 218 2408
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Neonc Technologies, Inc.

This content was sourced from clinicaltrials.gov

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