The Global Coalition for Adaptive Research (GCAR) announced recently that the GBM AGILE clinical trial is opening its first clinical site, the Henry Ford Cancer Institute, and has begun enrolling patients. GBM AGILE is the world’s first global adaptive clinical trial platform for glioblastoma and will ultimately evaluate multiple therapies simultaneously across trial sites on multiple continents for patients with newly diagnosed and recurrent glioblastomas.
Janet Woodcock, MD
The U.S. Food and Drug Administration has been a strong proponent of modernizing clinical trials with the use of master protocols, including platform trials, to support more efficient and less costly drug development.
“Understanding of glioblastoma biology over the past decade has led to few improvements in survival for patients with the disease. One clear barrier to progress is the inefficient clinical trial system for testing and developing new therapies and biomarkers in the clinic,” said Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at the FDA. “Developing new therapies for patients with glioblastoma will require more engagement from industry and enhanced learning from clinical trials. Platform trials can accelerate the time from discovery in the laboratory to implementation in the clinic.”
About GBM AGILE
GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. It is designed as a learning system to more efficiently and rapidly identify effective therapies for patients with glioblastoma. GBM AGILE’s nimble model enables multiple drugs to be screened simultaneously and over time. Drugs that show initial evidence of benefit to patients will seamlessly transition to a confirmatory stage designed to support drug approval. Drugs that are underperforming will be dropped. The intent is to lower the cost, time, and number of patients required to evaluate new, potentially effective therapies for patients with glioblastoma.
By the end of 2019, GBM AGILE will open in more than 40 academic medical centers and community-based institutions across the United States. There are plans to expand across Europe, China, Canada, and Australia through 2020. Although GM AGILE plans to test multiple drugs from different companies over time, the first drug entering the trial will be the multikinase inhibitor regorafenib. ■