NCT00586508

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	enzastaurin	1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
DRUG	bevacizumab	10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).
DRUG	Enzyme-inducing antiepileptic drugs (EIAED)	Administered orally
DRUG	Non-enzyme inducing antiepileptic drugs (NEIAED)	Administered orally

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2008-01-04
• Last updated: 2020-09-24
• Results posted: 2020-09-24

Locations

1 site across 1 country: United States