A Phase II/III Study of Regorafenib versus Standard Therapy for Patients with Newly Diagnosed or Recurrent Glioblastoma (GBM AGILE)

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GBM Agile

Purpose

Regorafenib is a drug used to treat certain digestive cancers. It may also be active against glioblastoma multiforme (GBM), an aggressive brain tumor. In this study, researchers are comparing the effectiveness of regorafenib with standard therapies in patients with newly diagnosed or recurrent GBM.

Regorafenib works by blocking an enzyme that cancer cells need to grow. Blocking this enzyme inhibits the development of blood vessels that cancer cells need to grow and spread. Patients in this study will be randomly assigned to receive either:

  • Temozolomide and radiation therapy for patients with newly diagnosed “unmethylated” GBM.
  • Lomustine for recurrent GBM.
  • Regorafenib. Patients in this group with newly diagnosed GBM will receive temozolomide and radiation therapy before starting treatment with regorafenib.

The medications used in this study are all taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed or recurrent GBM.
  • Patients with recurrent GBM may not participate if they had more than two prior regimens of chemotherapy, prior treatment with bevacizumab or another drug that inhibits tumor blood vessel growth, or previous therapy with prolifeprospan 20 with carmustine wafer or a medication delivered directly into the brain.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ingo Mellinghoff at 646-888-2766.

Protocol

19-346

Phase

II/III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators