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NCT02282917 · ClinicalTrials.gov registry record · Early Phase 1
Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
A Early Phase 1 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT02282917 is a Early Phase 1 study that was terminated before completion, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 7 participants.
The verdict
NCT02282917, a Early Phase 1 study, was terminated before completion, sponsored by Massachusetts Eye and Ear Infirmary.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study 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.
Interventions
- DRUG AR-42
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-01-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02282917
The ClinicalTrials.gov registry entry for NCT02282917 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AR-42 is the first listed.
NCT02282917 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02282917 about?
NCT02282917 is a clinical study titled "Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma". 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 ...
What is the current status of trial NCT02282917?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2015-12. Estimated completion is 2021-01-04.
What interventions are being tested in trial NCT02282917?
The interventions under investigation include: AR-42 (DRUG).
Who is sponsoring clinical trial NCT02282917?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
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