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A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Trial Status: closed to accrual
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.
Inclusion Criteria
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
Exclusion Criteria
Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
The presence of FGFR gatekeeper and resistance mutations
Histologic demonstration of urothelial carcinoma
Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
Active malignancies other than for disease requiring therapy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04083976.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationJanssen Research & Development, LLC