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Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586508
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : February 6, 2014
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: enzastaurin Drug: bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas
Study Start Date : November 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 or 875 mg, oral, daily, 4 week cycles with patients evaluated after each cycle. The dose difference is for patients who are on enzyme-inducing antiepileptic drugs versus non-enzyme inducing antiepileptic drugs.
Other Name: LY317615

Drug: bevacizumab
10mg/kg, IV, every 2 weeks, patients are evaluated after each cycle

Primary Outcome Measures :
  1. Time to progressive disease [ Time Frame: baseline to disease progression ]
  2. Safety [ Time Frame: every cycle ]

Secondary Outcome Measures :
  1. To evaluate tumor markers and genes [ Time Frame: baseline, every cycle ]
  2. Quality of life [ Time Frame: every cycle ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must be at least 18 years old
  • Patient must have been diagnosed with a recurrent brain tumor by MRI scan
  • Patient must be willing to practice adequate contraception
  • Patient must be able to swallow the Enzastaurin tablets whole and receive Bevacizumab intravenously
  • Patient must agree to use the study drug only as instructed by your study doctor and staff.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586508

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United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, United States
Sponsors and Collaborators
Eli Lilly and Company
Genentech, Inc.
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company Identifier: NCT00586508    
Obsolete Identifiers: NCT00559923
Other Study ID Numbers: 11394
H6Q-MC-S033 ( Other Identifier: Eli Lilly and Company )
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: October 2013
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors