Erdafitinib (RAGNAR 42756493CAN2002)
A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations
Rekrutierung beendet
Summary
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 6 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.
Key inclusion criteria
- Age ≥ 6 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
Sponsor
Janssen-Cilag