DIA 2017 Annual Meeting

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.

Chair

Donald A Berry, PhD

Speaker

Panelist
Mustafa Khasraw, MD

Panelist
Amy Heimberger, MD

Panelist
Brian Alexander, MD, MPH