drugset / Trial / NCT05773664

Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma

NCT05773664

RandomizedSequentialOpen-labelTreatment

Summary

This phase I trial tests the safety, side effects, and best dose of dexamethasone when given with azeliragon in managing cerebral edema after surgery (post-resection) in patients with glioblastoma. Cerebral edema is a pathological increase in the water mass contained within the brain interstitial space. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Azeliragon is an oral RAGE inhibitor. Blocking the RAGE pathway at the time of surgery (peri-operatively) may decrease cerebral edema. Giving dexamethasone with azeliragon may help control post-operative cerebral edema in decreasing doses of concurrently administered dexamethasone.

Timeline

Start
2024-11-15
Primary completion
2024-11-29
Completion
2024-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Azeliragon Small molecule Oral
Subject Dexamethasone Small molecule Oral

Indications