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Clinical Trial Summary

This is a phase 2 study to evaluate the safety and preliminary evidence of effectiveness of azeliragon, in combination with radiation therapy, as an initial treatment of a form of glioblastoma. Glioblastoma is a type of brain cancer that grows quickly and can invade and destroy healthy tissue. There's no cure for glioblastoma, which is also known as glioblastoma multiforme. Treatments, including surgery, radiation, and chemotherapy might slow cancer growth and reduce symptoms. New treatments of glioblastoma are needed.


Clinical Trial Description

The study to be conducted is a phase 2 study in newly diagnosed "unmethylated" glioblastoma. As compared to "methylated" glioblastoma "unmethylated" glioblastoma carries a worse prognosis, as it is resistant to temozolomide, the most commonly prescribed chemotherapeutic treatment. Based upon pre-clinical evidence suggesting that azeliragon may enhance the effectiveness of radiation, as well as have a delaying effect on disease progression, this study will combine daily oral azeliragon with radiation treatment, followed by continued administration of azeliragon after completion of radiation therapy. Azeliragon is administered once daily as an oral capsule. In previous studies in patients with Alzheimer's disease and in normal volunteers, azeliragon was well tolerated for up to 18 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05986851
Study type Interventional
Source Cantex Pharmaceuticals
Contact Stephen G Marcus, MD
Phone 9543153660
Email info@cantex.com
Status Recruiting
Phase Phase 2
Start date September 12, 2023
Completion date June 30, 2025

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