A Randomized Double-Blind Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1

Brief description of study

The purpose of the study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients. Enzastaurin, an acyclic bisindolylmaleimide, is a potent and selective inhibitor of protein kinase C beta. The study drug enzastaurin is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01515
ClinicalTrials.gov Identifier: NCT03776071
Principal Investigator: Christine Cordova.


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