Trial to Test Different Treatments for Newly Diagnosed and Recurrent Glioblastoma

Sponsor: Global Coalition for Adaptive Research

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03970447

Provider View

This study is exploring various treatments for patients with newly diagnosed or returning glioblastoma, a type of brain cancer. The trial aims to find effective therapies and match them to specific patient groups.

Patient Parameters

Program Overview

This international study, called GBM AGILE, is testing multiple treatments for glioblastoma, a type of brain cancer, in patients who are newly diagnosed or have had the cancer return. The study uses a special method to assign treatments based on how well they work for different patient groups. The main goal is to see if these treatments can help patients live longer. The trial allows for testing many drugs from different companies at the same time, and new treatments can be added as they are discovered.

Description

GBM AGILE is a global study designed to find effective treatments for glioblastoma, a serious brain cancer. It tests different therapies in patients who are newly diagnosed or have had the cancer return. The study uses a method that adapts to how well treatments are working for different groups of patients. The main focus is on improving overall survival rates.

The trial is set up to efficiently test many drugs and drug combinations from various pharmaceutical companies. It operates under a single protocol, which means it can quickly add new promising treatments and remove those that have been fully evaluated. This approach helps in identifying the best therapies for different types of glioblastoma.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Grade IV glioblastoma, including gliosarcoma, after surgery or biopsy.
  • Have an MRI scan done within 21 days before starting the trial.
  • Have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
  • Provide a tumor sample from surgery or biopsy.

For Recurrent Glioblastoma:

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Grade IV glioblastoma at first or second recurrence after initial treatment, including radiation.
  • Show evidence of cancer returning based on specific criteria.
  • Have two scans confirming cancer progression.
  • Have a performance status score of 70% or higher.
  • Provide a tumor sample from initial or recurrent surgery, if available.

Exclusion Criteria

  • Have received any prior treatment for glioma, including certain drugs or radiation.
  • Have extensive disease affecting the brain's protective layers.
  • Have a heart condition with specific QTc interval measurements.
  • Have had another cancer in the past 2 years, except for certain skin cancers.

For Recurrent Glioblastoma:

  • Have early disease progression within 3 months after radiation.
  • Have had more than two prior chemotherapy treatments.
  • Have received certain drugs or treatments that are part of the trial.
  • Have extensive disease affecting the brain's protective layers.
  • Have a heart condition with specific QTc interval measurements.
  • Have had another cancer in the past 2 years, except for certain skin cancers.

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