Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

Lilly

Status and phase: Completed; Phase 2

Conditions: Recurrent Glioblastoma

Treatments: Drug: Non-enzyme inducing antiepileptic drugs (NEIAED); Drug: enzastaurin; Drug: bevacizumab; Drug: Enzyme-inducing antiepileptic drugs (EIAED)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586508

H6Q-MC-S033 (Other Identifier)

11394

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be at least 18 years old
• Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
• Participant must be willing to practice adequate contraception
• Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
• Participant must agree to use the study drug only as instructed by your study doctor and staff.

Exclusion criteria

• Women who are pregnant or breastfeeding
• Participants who have significant heart, liver, kidney, or psychiatric disease
• Participants who have an active infection
• Participants who have any recent bleeding in the brain
• Participants who are taking any anti-coagulation or anti-platelet medication [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors]

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Enzastaurin + Bevacizumab

Experimental group

Treatment:

Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)

Drug: enzastaurin

Drug: bevacizumab

Drug: Enzyme-inducing antiepileptic drugs (EIAED)