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

Glioblastoma Clinical Trial

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

Clinical Trial Summary

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

Clinical Trial Description

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS). GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03970447
Study type Interventional
Source Global Coalition for Adaptive Research
Contact Patient Information
Phone 310-598-3199
Email patientinfo@gcaresearch.org
Status Recruiting
Phase Phase 2/Phase 3
Start date July 30, 2019
Completion date June 2028
View Details
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