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NCT00402116 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00402116 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 72 participants.
The verdict
NCT00402116, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study 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.
Interventions
- DRUG temozolomide
- RADIATION radiation therapy
- DRUG enzastaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402116
The ClinicalTrials.gov registry entry for NCT00402116 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which temozolomide is the first listed.
NCT00402116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402116 about?
NCT00402116 is a clinical study titled "Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients". 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...
What is the current status of trial NCT00402116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2006-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00402116?
The interventions under investigation include: temozolomide (DRUG), radiation therapy (RADIATION), enzastaurin (DRUG).
Who is sponsoring clinical trial NCT00402116?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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