NCT04083976

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

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered as the time when the last participant receives the last dose of study drug on the study and either all pediatric participants are off study or until the most recently enrolled pediatric participant still participating in the study has 6 months of follow-up, whichever occurs first. Currently this study is recruiting pediatric participants only.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Erdafitinib	Participants will receive erdafitinib oral tablets.

Timeline

• Start date: 2019-11-20
• Primary completion: 2023-12-04
• Completion: 2026-12-31
• First posted: 2019-09-10
• Last updated: 2026-03-19
• Results posted: 2025-02-24

Locations

171 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, China, France, Germany, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study