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Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00586508
First received: December 7, 2007
Last updated: January 7, 2014
Last verified: October 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586508

Locations
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.
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov 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:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014