drugset / Trial / NCT00402116

Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients

NCT00402116

NaSingle-groupOpen-labelTreatment

Summary

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study. The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects. In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.

Timeline

Start
2006-09
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 200 mg/m2 Oral
Subject enzastaurin Small molecule 250 mg Oral
Subject enzastaurin Small molecule 500 mg Oral

Indications