The Global Coalition for Adaptive Research (GCAR), the organization sponsoring the GBM AGILE clinical trial platform, announced today that it is officially opening its first trial site, the Henry Ford Cancer Institute, and will begin enrolling patients on its first treatment arm with the Bayer drug regorafenib.
GBM AGILE (Adaptive Global Innovative Learning Environment) is the first-ever global adaptive clinical trial platform for brain cancer patients, and will ultimately evaluate multiple therapies simultaneously in different treatment arms and at trial sites across several continents. The intent of the trial is to lower the time, cost, and number of patients required to evaluate potentially efficacious therapies for both newly diagnosed and recurrent glioblastoma (GBM) patients. By the end of 2019, GBM AGILE will open to over 40 academic medical centers and community-based institutions across the United States, with plans to expand across Australia, Canada, China, and Europe through 2020.
The following is a statement from David F. Arons, JD, Chief Executive Officer of the National Brain Tumor Society (NBTS):
“It has been very encouraging to watch GBM AGILE continue progressing from a novel concept supported by the top minds in neuro-oncology to an active clinical trial platform ready to enroll patients and evaluate new, potentially better treatment options for a patient population that desperately needs them.
“We congratulate the team at GCAR for continuing to move this exciting effort forward, as well as all their hard work and commitment to reimagining how the brain tumor field can approach clinical research and drug development in a more effective, efficient manner. We also appreciate Bayer’s engagement to utilize the innovative nature and unique benefits of the GBM AGILE platform to further evaluate the use of regorafenib in glioblastoma patients.
“NBTS has supported the idea of a global effort to launch an adaptive platform trial with a master protocol in glioblastoma since its inception and it’s gratifying to see this vision become a reality. We firmly believe GBM AGILE will transform and enhance the clinical trial process for stakeholders across the glioblastoma R&D landscape, from patients to researchers to biopharmaceutical companies. As such, we encourage additional industry partners to join us in our collective efforts and help speed up the anticipated benefits that GBM AGILE stands to deliver to the brain tumor community.”
National Brain Tumor Society, along with the National Foundation for Cancer Research and the Asian Fund for Cancer Research, is a key strategic partner for GCAR and the GBM AGILE platform, providing philanthropic and advocacy support. NBTS has worked with our partners, including StacheStrong, to invest in the GBM AGILE trial.
-GBM AGILE ClinicalTrials.gov listing (NCT03970447): http://bit.ly/AGILENCTN