A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Solid Tumor
Unknown Primary
6 Years and older, Male and Female
CR108661 (primary)
NCI-2019-07959
42756493CAN2002
2019-002113-19
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.
Eligibility
- Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
- Measurable disease
- Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
- Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening
Treatment Sites in Georgia
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