Researchers to launch multinational precision medicine trial for deadliest brain tumor

The trial, called GBM Agile, will test various treatments depending on the molecular profile of a patient’s tumor.

Treatments that do not work will be dropped from the study to enable patients to start on other agents or combinations.

The study will be carried out using a master protocol, developed by the US Food and Drug Administration (FDA).

The approach will allow centralizing several functions, and simplifying the efforts required to add new therapies to the ongoing trial process.

Molecular biomarkers will be used to assign specific patients to matching therapies of the study, which will start enrolling patients by mid-2016.

The trail is being developed through the National Biomarker Development Alliance (NBDA), a non-profit organization created as part of the Research Collaboratory at Arizona State University.

GBM Agile co-investigator Web Cavenee said: "This new generation of clinical trials will be adaptive based on learning from the patients; global as it is to be performed across the U.S., China, Australia and Europe; and innovative in that it is driven by Bayesian statistics and molecular markers.

"The nature of this trial is that it will be a ‘learning environment’ that allows the response of each patient to inform the ongoing conduct of the trial."

About 12,000 people in the US and several more across the globe, including 35,000 in China alone, are expected to be diagnosed with GBM this year.