Back to Agenda
GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial
Session Chair(s)
Donald A Berry, PhD
Professor, Department of Biostatistics
M.D. Anderson Cancer Center, United States
Glioblastoma (GBM), is the most common of adult brain tumors; and with 50% of patients dying in the first year post diagnosis and a 5 year survival of 5%, it remains among the most lethal of all cancers. Large numbers of GBM clinical trials have been performed on nearly all classes of potential therapies. However, with one exception, a single cytotoxic, temozolomide, have failed to produce meaningful increases in survival. Therefore, the treatment of GBM has not changed significantly for decades. Ironically, due to projects like The Caner Genome Atlas, GBM is one of the most comprehensively molecularly characterized tumors to date. GBM AGILE is the product of an unprecedented global collaboration of over 130 leaders from across the neur-oncology communities that seeks to change this dismal reality.
This session will discuss GBM AGILE, a transformative, Bayesian statistics driven global platform trial where successful agents will proceed seamlessly vial algorithm through two seamless stages. In its essence, GBM AGILE’s two stages combines classic phase 2 screening and registration trials, and in doing so, makes the best use of limited patient resources and offers unprecedented opportunities to increase the efficiency of drug/biologics development.
Learning Objective : Discuss the overall statistical design, unique features and patient advantages of GBM AGILE; Describe aspects of GBM AGILE that are potentially transformative for therapeutics development.
Speaker(s)
Panelist
Mustafa Khasraw, MD
University of Sydney, Australia
Associate Professor
Panelist
Amy Heimberger, MD
University of Texas MD Anderson Cancer Center, United States
Professor in the Department of Neurosurgery
Panelist
Brian Alexander, MD, MPH
Foundation Medicine, United States
Chief Executive Officer
Have an account?