Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: December 7, 2007
Last updated: January 7, 2014
Last verified: October 2013
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment recurrent malignant gliomas.

Condition Intervention Phase
Recurrent Glioblastoma
Drug: enzastaurin
Drug: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to progressive disease [ Time Frame: baseline to disease progression ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate tumor markers and genes [ Time Frame: baseline, every cycle ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00586508

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.
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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eli Lilly and Company Identifier: NCT00586508     History of Changes
Obsolete Identifiers: NCT00559923
Other Study ID Numbers: 11394  H6Q-MC-S033 
Study First Received: December 7, 2007
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 04, 2016