A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE)

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE)

Trial Summary

Official Title

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Status

Recruiting

Condition

Glioblastoma

Actual Start Date

July 30, 2019

Estimated Primary Completion Date

December 2023

GBM AGILE is an international, seamless Phase II/III, flexible and response adaptive trial designed to evaluate several "treatment arms," giving it the potential to fundamentally change the clinical research process for GBM by identifying or disproving therapies more quickly. GBM AGILE is an entirely unique approach to clinical trials made possible by the partnership and collaboration of clinicians, researchers, governments, regulatory agencies, pharmaceutical companies, and patient advocacy groups.

 

Relevant Press Releases

Enrollment

For more information on enrollment into the current VAL-083 trial, please contact us or visit clinicaltrials.gov for location information.

The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.