GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM
July 30, 2019
GBM AGILE is an international, seamless Phase II/III, flexible and response adaptive trial designed to evaluate several "treatment arms," giving it the potential to fundamentally change the clinical research process for GBM by identifying or disproving therapies more quickly. GBM AGILE is an entirely unique approach to clinical trials made possible by the partnership and collaboration of clinicians, researchers, governments, regulatory agencies, pharmaceutical companies, and patient advocacy groups.
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The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.