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Monday, June 19 • 11:00am - 12:15pm
#122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-572-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Donald A Berry, PhD


Mustafa Khasraw, MD

Amy Heimberger, MD

Brian Alexander, MD, MPH


Brian Alexander

Associate Professor of Radiation Oncology, Harvard Medical School, Dana-Farber Cancer Institute
Brian Alexander is an Associate Professor of Radiation Oncology at Harvard Medical School. He leads the Program for Innovations in Therapeutic and Biomarker Development at the Dana-Farber Cancer Institute and is the Deputy Director for Regulatory Science at the Harvard/MIT Center... Read More →

Donald Berry

Professor, Department of Biostatistics, M.D. Anderson Cancer Center
Donald Berry is a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He has held endowed faculty positions at Duke University and at M.D. Anderson. Dr. Berry has authored over 400 publications. He is listed by ScienceWatch.com as... Read More →

Amy Heimberger

Professor in the Department of Neurosurgery, University of Texas MD Anderson Cancer Center
avatar for Mustafa Khasraw

Mustafa Khasraw

Associate Professor, University of Sydney
Senior Research Fellow/ Clinical Lead at the National Health and Medical Research Council Clinical Trials Centre, University of Sydney and medical oncologist at Royal North Shore Hospital (RNSH) where he originally completed his medical oncology training in Sydney and subsequentl... Read More →

Monday June 19, 2017 11:00am - 12:15pm
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Statistics
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session