GBM AGILE Adaptive Platform Trial Recruiting in Australia

Austin Health in Melbourne and Royal North Shore Hospital in Sydney are Now Enrolling Patients

Planned Expansion to Include 4 Additional Trial Locations in Australia

The Global Coalition for Adaptive Research (GCAR) in collaboration with Cure Brain Cancer Foundation (CBCF), today announced the opening of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447) in Australia. GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that evaluates multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

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Since opening for enrollment in June 2019, GBM AGILE has screened over 1700 patients in North America and Europe. Expansion of the trial to include hospitals in Australia marks a major milestone that greatly increases options and access to experimental therapies for Australians diagnosed with GBM. Prof Hui Gan of Austin Health is serving as the Regional Principal Investigator for Australia. An additional 4 sites in Brisbane, Newcastle, and Adelaide are scheduled to open over the next several months.

“Glioblastoma is a devastating aggressive brain cancer. Despite surgery, chemotherapy, and radiation, the median survival rate is a mere 14 months. There is a profound need for new and better treatment options for patients,” said Prof Hui Gan, Director, Cancer Clinical Trials Centre, Austin Health and GBM AGILE Regional PI, Australia. “GBM AGILE has been designed to evaluate new therapies in the most efficient way possible.”

“We are excited to be one of the first sites to open GBM AGILE in Australia, a study which aligns with our commitment to finding patients the best possible treatments,” said Dr. Helen Wheeler, principal investigator for GBM AGILE at Royal North Shore Hospital.

GBM AGILE is a patient-centric clinical trial that uses adaptive randomization to dynamically adjust how treatments are assigned to patients. The trial, conceived by over 130 key opinion leaders, allows multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, GBM AGILE accelerates the evaluation of promising therapies for patients with glioblastoma, and ultimately could lead to new treatment options for patients sooner.

“Cure Brain Cancer Foundation is an organization dedicated to rapidly improving brain cancer survival and ultimately finding a cure. We are thrilled that patients in Australia will be able to participate in this innovative clinical trial,” said Lance Kawaguchi, CEO, Cure Brain Cancer Foundation. “Our organization is proud to have committed almost 8 million AUD to support the infrastructure build of GBM AGILE in Australia. We are proud to have delivered on a promise we made to our community to bring GBM AGILE to Australia.”

“GCAR is committed to providing access to innovative clinical trials globally with the hope that this will advance new treatment options to support all patients who need them,” said Dr. Meredith Buxton, CEO & President of GCAR. “We celebrate the dedication and persistence of the patient and scientific community and acknowledge the resoluteness and financial support of the Cure Brain Cancer Foundation. Bringing GBM AGILE to Australia has been an important goal since the trial’s inception, and we thank the community’s unwavering support that has made this happen.”

To view GBM AGILE eligibility criteria and a list of trial locations, please visit: https://clinicaltrials.gov/study/NCT03970447

About Global Coalition for Adaptive Research (GCAR)

The Global Coalition for Adaptive Research (GCAR) unites physicians, clinical researchers, advocacy and philanthropic organizations, biotech/pharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases. As Sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. Adaptive platform trials can accelerate the time from discovery in the lab to implementation in the clinic resulting in better treatments and lives saved. To learn more about GCAR and its initiatives, visit gcaresearch.org.

About Cure Brain Cancer Foundation (CBCF)

Cure Brain Cancer Foundation is an Australian-based organization that is working globally to rapidly improve brain cancer survival through funding innovative brain cancer research. Cure Brain Cancer Foundation is the largest dedicated funder of brain cancer research in Australia. The Foundation has invested over $30 million into brain cancer research including clinical trials and pre-clinical research efforts across pediatric and adult brain cancers. The Foundation passionately forges global research collaborations, brings world-class clinical trials to Australia, and gives people with brain cancer greater access to innovative new treatments. The Foundation’s mission is to unite the community and rapidly increase brain cancer survival, improving the quality of life for people impacted by the disease. With a vision to ultimately find a cure for brain cancer. For more information visit www.curebraincancer.org.au

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