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Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

NCT03825484 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2025-06-13

No results posted yet for this study

Summary

The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration \[FDA\] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.

Conditions

  • Advanced Cancers and FGFR Genetic Alterations

Interventions

DRUG

Erdafitinib

Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825484 on ClinicalTrials.gov