Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03970447
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2019-05-23
Brief Title:
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Sponsor:
Global Coalition for Adaptive Research
Organization:
Global Coalition for Adaptive Research
Study Overview
Official Title:
GBM AGILE Global Adaptive Trial Master Protocol an International Seamless Phase IIIII Response Adaptive Randomization Platform Trial Designed to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent GBM
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GBM AGILE
Brief Summary:
Glioblastoma GBM adaptive global innovative learning environment GBM AGILE is an international seamless Phase IIIII response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed ND and recurrent GBM
Detailed Description:
Glioblastoma GBM adaptive global innovative learning environment GBM AGILE is an international seamless Phase IIIII 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 ApplicationClinical 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
GBM AGILE is designed to efficiently evaluate therapies The trial will be conducted under a single Master Investigational New Drug ApplicationClinical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None