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

  • STATUS
    Recruiting
  • End date
    Sep 12, 2025
  • participants needed
    280
  • sponsor
    Janssen Research & Development, LLC
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Updated on 9 January 2021
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Investigator
The Medical Research Network, LLC
Primary Contact
Chris O'Brien Lifehouse (7.3 mi away) Contact
+257 other location
cancer
measurable disease
growth factor
solid tumour

Summary

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.

Description

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.

Details
Treatment Erdafitinib
Clinical Study IdentifierNCT04083976
SponsorJanssen Research & Development, LLC
Last Modified on9 January 2021

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have Advanced Solid Tumor?
Do you have any of these conditions: Advanced Solid Tumor or Advanced Malignant Solid Tumor?
Do you have any of these conditions: Advanced Malignant Solid Tumor or Advanced Solid Tumor?
Do you have any of these conditions: Advanced Malignant Solid Tumor or Advanced Solid Tumor?
Do you have any of these conditions: Advanced Malignant Solid Tumor or Advanced Solid Tumor?
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
Clear my responses
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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