Erdafitinib in solid tumors with FGFR gene alterations (RAGNAR)

“A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations.”

The aim of the study is to find out whether treatment with erdafitinib is safe and effective in adolescents with solid tumors with a certain change (alteration) in the FGFR gene (Fibroblast Growth Factor Receptor). In various tumors there is a dysregulation of the FGFR gene with permanent activation of the receptor, which sustains tumor growth.

Erdafitinib binds to the FGFR subtypes FGFR1-FGFR4. This inhibits the enzymatic activity of these receptors - the subsequent signaling pathways stop. This leads to the death of tumor cells and a slowdown in tumor growth.

Patients 12 years of age and older with advanced solid tumors or brain tumors can participate in this study. An FGFR mutation or fusion in the tumors must be proven by molecular diagnostics.

Erdafitinib is taken in tablet form continuously in cycles of 21 days.

Inclusion of patients in Heidelberg has been possible since 10 June 2021.

  • Age ≥ 12 years
  • Patients with an unresectable, locally advanced, or metastatic solid tumor malignancy bearing an FGFR mutation or fusion, as determined by local or central laboratory screening
  • Karnofsky oder Lansky > 80

For more information, see the Study Registry: The study is registered with the U.S. National Institutes of Health (ClinicalTrials.gov).
See NCT04083976

EudraCT-Number: 2019-002113-19 (Clinical Trials Register)