Last updated on June 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Solid Tumor
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

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 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 30 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) before the first dose of erdafitinib
  • The presence of FGFR gatekeeper and resistance mutations
  • Histologic demonstration of transitional cell carcinoma of the urothelium (that is [i.e.], bladder cancer)
  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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