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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 DGM1PI
This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all eligibility criteria will be enrolled.
Primary: 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 DGM1 biomarker-positive patients, regardless of MGMT methylation status. Secondary: To compare progression free survival (PFS) in DGM1 biomarker-positive patients between treatment arms, regardless of MGMT methylation status To compare objective response rate (ORR) in DGM1 biomarker-positive patients between treatment arms, regardless of MGMT methylation status To further evaluate the safety profile of enzastaurin in combination with radiation therapy plus temozolomide and in combination with temozolomide Exploratory: To evaluate OS in DGM1 biomarker-negative patients To determine if the presence of chromaturia (orange/red discoloration of urine) correlates with improved survival in patients taking enzastaurin To analyze for the presence of enzastaurin and enzastaurin metabolites in urine (urine pharmacokinetics [PK]) To evaluate if the presence of other somatic or tumor biomarkers correlates with improved efficacy in patients taking enzastaurin To determine enzastaurin and enzastaurin metabolite(s) concentrations for incorporation into a subsequent population PK analysis
Placebo (); Radiotherapy (); Temodal (Temozolomide); Temozolomide (); enzastaurin (LY317615)
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