Status:
APPROVED_FOR_MARKETING
Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Advanced Cancers and FGFR Genetic Alterations
Eligibility:
All Genders
Brief 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 p...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participant has a documented fibroblast growth factor receptor (FGFR) alteration
- Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment)
- Life expectancy is greater than (\>) 3 months (determined by treating physician's assessment)
- Participant has exhausted treatment options for their disease (review of prior treatments)
- Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03825484
Last Update
June 13 2025
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