NCT00402116

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

Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Glioblastoma Multiforme
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	enzastaurin	Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles
DRUG	temozolomide	75 milligrams per meter squared (mg/m\^2), oral, daily, 6 weeks then 200 mg/m\^2, oral, daily, twelve 28 day cycles
RADIATION	radiation therapy	1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-11-22
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

1 site across 1 country: United States