NCT05986851

Azeliragon in MGMT Unmethylated Glioblastoma

A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients With MGMT Unmethylated Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cantex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Azeliragon	Oral capsule

Timeline

• Start date: 2023-09-12
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2023-08-14
• Last updated: 2026-03-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study