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TERMINATED
NCT02282917
EARLY_PHASE1

Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma

Sponsor: Massachusetts Eye and Ear Infirmary

View on ClinicalTrials.gov

Summary

This will be a multi-center, proof of concept phase 0 study to assess the suppression of p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing tumor resection. AR-42 is a small molecule which crosses the blood brain barrier (BBB) in rodents, but the investigators are not certain yet if it will penetrate human VS. Meningiomas are outside the BBB, but seem to be unusually resistant to all current medical treatments. The primary endpoint of the bioactivity of suppression of p-AKT by AR-42 was selected as drug activity seems more informative than bioavailability. Our preclinical data and others have shown dose dependent suppression of p-AKT by AR-42 in both VS and meningiomas.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2015-12

Completion Date

2021-01-04

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

AR-42

AR-42 will be administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, will be self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. The treating surgeon will perform the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.

Locations (4)

Stanford University

Stanford, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States