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
Objective
Primary Objective To assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with RT followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in DGM1 biomarker-positive patients
Secondary Objectives To compare progression free survival (PFS) in DGM1 biomarker-positive patients between treatment arms To compare objective response rate (ORR) in DGM1 biomarker-positive patients between treatment arms To further evaluate the safety profile of enzastaurin in combination with RT plus temozolomide and in combination with temozolomide
