Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma
Exploratory, Phase II study designed to assess anti-tumor activity of combinatorial regimen
consisting of erlotinib + bevacizumab among pts w recurrent malignant glioma. Signal
transduction inhibitors, such as erlotinib, as well as anti-angiogenic agents, such as
bevacizumab, are expected to exert a cytostatic anti-tumor effect. Primary endpoint of study
is probability of progression-free survival at 6 months. An important secondary objective is
to further assess the safety of erlotinib + bevacizumab for pts w RMG. Pharmacokinetic
studies included in protocol will evaluate impact of enzyme-inducing anti-epileptic drugs
(EIAEDs) on metabolism of erlotinib.
If study demonstrates that combo regimen of erlotinib + bevacizumab is associated w
encouraging anti-tumor activity among pts w recurrent malignant glioma (RMG), further
assessment of regimen in additional ph II & possibly ph III studies, will be considered.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6 Month Progression-free Survival
The proportion of patients alive and progression free at 6 months
6 months
No
David A. Reardon, MD
Principal Investigator
Duke University Health System
United States: Food and Drug Administration
Pro00000220
NCT00671970
February 2007
April 2010
Name | Location |
---|---|
Duke University Health System | Durham, North Carolina 27705 |