A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Summary

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

Timeline

Start

2019-11-20

Primary completion

2023-12-04

Completion

2026-02-28

Publications

• Carranza O, Pant S, Schuler M, Witt O, Geoerger B, Loriot Y, Farouk Sait S, Arnold D, Dal Molin GZ, Lugowska I, Winter H, Baldini C, Corassa M, Thomas S, Crow L, Xia Y, Triantos S, Sweiti H, Reardon DA. Erdafitinib in Patients With Advanced Solid Tumors With FGFR Alterations (RAGNAR): Results of Tumor-Specific Analyses and Secondary Cohorts. JCO Precis Oncol. 2026 Jul;10(7):e2501094. doi: 10.1200/PO-25-01094. Epub 2026 Jul 15.
• Pant S, Schuler M, Iyer G, Witt O, Doi T, Qin S, Tabernero J, Reardon DA, Massard C, Minchom A, Lugowska I, Carranza O, Arnold D, Gutierrez M, Winter H, Stuyckens K, Crow L, Najmi S, Hammond C, Thomas S, Santiago-Walker A, Triantos S, Sweiti H, Loriot Y; RAGNAR Investigators. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study. Lancet Oncol. 2023 Aug;24(8):925-935. doi: 10.1016/S1470-2045(23)00275-9.

Drugs

Indications