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| Sponsored by: |
Eli Lilly and Company |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00295815 |
Purpose
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
| Condition | Intervention | Phase |
|
Glioblastoma |
Drug: enzastaurin Drug: lomustine |
Phase III |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Lomustine Enzastaurin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma |
| Estimated Enrollment: | 397 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | February 2008 |
| Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
|
| B: Active Comparator |
Drug: lomustine
100-130 mg/m2, oral once, every 6 weeks until PD
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 98 Study Locations |
| Eli Lilly and Company |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 9817, H6Q-MC-JCBF |
| First Received: | February 22, 2006 |
| Last Updated: | December 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00295815 |
| Health Authority: | United States: Food and Drug Administration |
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