Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-044
Prinicipal Investigator
Aregawi, Dawit
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
DB102-01
Title
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
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center