drugset / Trial / NCT00402116
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
Phase 1/2
Completed
72 enrolled
Eli Lilly and Company
University of California, San Francisco · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |
| Subject | enzastaurin | Small molecule | 250 mg | Oral |
| Subject | enzastaurin | Small molecule | 500 mg | Oral |