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

  • End date
    Sep 11, 2026
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 26 July 2021
The Medical Research Network, LLC
Primary Contact
Highlands Oncology Group (1.2 mi away) Contact
+265 other location
measurable disease
growth factor
solid tumour


The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions.


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 participants has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is defined as 4 years from enrollment of last participant into study or last follow-up visit of last patient, whichever occurs first.

Condition Advanced Solid Tumor, Advanced Malignant Solid Tumor
Treatment Erdafitinib
Clinical Study IdentifierNCT04083976
SponsorJanssen Research & Development, LLC
Last Modified on26 July 2021


Yes No Not Sure

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
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 greater 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, and BRAF V600E
Active malignancies other than for disease requiring therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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