A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion
National Cancer Institute (NCI)
Summary
This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT), FGFR-TACC gene fusion positive gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of, or to shrink, tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.
Description
PRIMARY OBJECTIVE: I. To assess the preliminary anti-tumor activity of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion as measured by the best response at any time during treatment in terms of objective response rate (ORR). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion. II. To assess the overall survival (OS) of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion. III. To assess the p…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have histologically confirmed IDH-WT gliomas (grade 2-4) as per World Health Organization (WHO) 2016 or 2021 classification * Tumor tissue should be positive for FGFR-TACC gene fusion as per any local next generation sequencing (NGS) (Clinical Laboratory Improvement Act \[CLIA\]-approved) assay described in background section * The disease should be recurrent or progressive glioma after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and/or chemotherapy * For…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood and/or tissue samples
- DrugErdafitinib
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureOptical Coherence Tomography
Undergo OCT
Locations (27)
- UCHealth University of Colorado HospitalAurora, Colorado
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida
- Memorial Hospital EastShiloh, Illinois
- Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, Missouri