Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
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
NCT Number:
NCT03970447
Phase:
II/III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Brain and Nervous System
Study Objectives:
5.1 Primary Objectives
The primary objectives of the study are:
1. To identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment.
2. To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
5.2 Secondary Objectives
The secondary objectives of the study are:
1. To evaluate PFS by each biomarker/therapeutic combination.
2. To evaluate OS by each biomarker/therapeutic combination.
3. To determine short- and long-term safety signals and QOL measures of an experimental Arm in GBM patients versus standard of care.
5.3 Exploratory Objectives
The primary objectives of the study are:
1. To generate general prognostic and predictive biomarker hypotheses.
2. To build and validate a longitudinal endpoint model of OS comprised of early assessments (performance status, disease progression, etc.) that are associated with OS.
Study Documents
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