drugset / Trial / NCT03825484

Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

NCT03825484

Expanded access Approved for marketing Janssen Scientific Affairs, LLC

Summary

The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration \[FDA\] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Erdafitinib Small molecule 9 mg Oral

Indications

No indication recorded.