Text Size

Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00586508
First received: December 7, 2007
Last updated: September 20, 2012
Last verified: September 2012
History of Changes

December 7, 2007
September 20, 2012
November 2007
November 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00586508 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial of Enzastaurin and Bevacizumab in Adults With Recurrent Malignant Gliomas
A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment recurrent malignant gliomas.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Glioblastoma
  • 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
Experimental: A
Interventions:
  • Drug: enzastaurin
  • Drug: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
November 2014
November 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586508
11394, H6Q-MC-S033
No
Eli Lilly and Company
Eli Lilly and Company
Genentech
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
Eli Lilly and Company
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP