Summary:
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0 clinical trial to evaluate infigratinib in patients with recurrent high-grade glioma driven by FGFR (fibroblast growth factor receptor) genetic alterations.
The goal of this study is to confirm that infigratinib can cross the blood-brain barrier. Patients with positive results may receive continued treatment in an expansion arm of the trial. We will also confirm if the study drug is hitting the molecular targets.
- FGFR (fibroblast growth factor receptor) genetic alterations have been shown to spur growth in malignant tumors.
- Five to seven percent of glioblastoma patients’ tumors are driven by FGFR signaling.
- Tumors relying on the FGFR gene fusion may demonstrate an ‘oncogene addiction’ that causes them to rely on this genetic anomaly to survive.
- Infigratinib is an orally administered, FGFR1-3 selective tyrosine kinase inhibitor from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc.
Criteria:- You are 18 years or older
- You have had prior resection (surgical removal) of a histologically diagnosed high-grade glioma (III and IV)
- You have been treated with radiation and a chemotherapy drug called temozolomide
- Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed)
- You have enough archival tumor tissue available from previous surgery to conduct genetic testing for the presence of FGFR3-TACC3 fusion gene or mutations in the FGFR1 and 3 genes.
Qualified Participants May Receive:
As part of a clinical trial at the Ivy Brain Tumor Center, the study drugs will be provided free of charge, however, the patient and/or their health plan/insurance company will be responsible for some or all of the costs of treating the tumor in the study, including any standard medical care such as surgical resection.