Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Recurrent Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enzastaurin + Bevacizumab

Group Type EXPERIMENTAL

enzastaurin

Intervention Type DRUG

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).

bevacizumab

Intervention Type DRUG

10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).

Enzyme-inducing antiepileptic drugs (EIAED)

Intervention Type DRUG

Administered orally

Non-enzyme inducing antiepileptic drugs (NEIAED)

Intervention Type DRUG

Administered orally

Interventions

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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).

Intervention Type DRUG

bevacizumab

10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).

Intervention Type DRUG

Enzyme-inducing antiepileptic drugs (EIAED)

Administered orally

Intervention Type DRUG

Non-enzyme inducing antiepileptic drugs (NEIAED)

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY317615

Eligibility Criteria

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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 \[including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors\]

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No