OncoMatch/Clinical Trials/NCT05859334
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
Is NCT05859334 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Erdafitinib for recurrent glioma.
Treatment: Erdafitinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
histologically confirmed IDH-WT gliomas
Required: IDH2 wild-type
histologically confirmed IDH-WT gliomas
Required: FGFR1 FGFR-TACC gene fusion
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
Required: FGFR2 FGFR-TACC gene fusion
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
Required: FGFR3 FGFR-TACC gene fusion
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
Disease stage
Required: Stage II, III, IV (WHO 2016 or 2021)
measurable disease (enhancing or non-enhancing as per Response Assessment in Neuro-Oncology [RANO] or RANO-low-grade glioma [LGG] criteria)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgical resection
after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and/or chemotherapy
Must have received: radiation therapy
after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and/or chemotherapy
Must have received: chemotherapy
after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and/or chemotherapy
Cannot have received: FGFR inhibitor
Patients who have previously received FGFR inhibitors
Lab requirements
Blood counts
Absolute neutrophil count >= 1000/uL; Hemoglobin > 8 g/dL (transfusion allowed); Platelets >= 100 x 10^9/L
Kidney function
Creatinine clearance > 30 mL/min (Cockroft-Gault estimation)
Liver function
Serum total bilirubin <= 1.5 x ULN (unless Gilbert's disease or disease involvement); AST/ALT <= 3 x institutional ULN
Cardiac function
NYHA Functional Classification class 2B or better; QTc <= 480 ms (Fridericia, ECG at screening)
Absolute neutrophil count >= 1000/uL; Hemoglobin > 8 g/dL (Patients are allowed to be transfused to this level); Platelets >= 100 x 10^9/L; Serum total bilirubin <= 1.5 x ULN, unless considered due to Gilbert's disease or disease involvement following approval by the medical monitor; AST/ALT <= 3 x institutional ULN; Creatinine clearance > 30 mL/min (Cockroft-Gault); NYHA Functional Classification class 2B or better; QTc > 480 ms (exclusion)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCHealth University of Colorado Hospital · Aurora, Colorado
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, Florida
- Memorial Hospital East · Shiloh, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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