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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
GlioblastomaGlioblastoma MultiformeGliosarcoma
Interventions
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

Trial Locations (1)

Unknown

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, San Francisco

All Listed Sponsors
collaborator

University of California, San Francisco

OTHER

lead

Eli Lilly and Company

INDUSTRY

NCT00402116 - Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients | Biotech Hunter | Biotech Hunter