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

Active:	No
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT04083976
Trial Phases:	Phase II	Protocol IDs:	CR108661 (primary) NCI-2019-07959 42756493CAN2002 2019-002113-19
Eligibility:	6 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04083976

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.

Objectives

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.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 700
Athens, GA 30607
706-353-2990 x279
www.universitycancer.com

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