Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
Sponsor: Janssen Scientific Affairs, LLC
ClinicalTrials ID:NCT03825484
This Expanded Access Program provides erdafitinib to participants with FGFR genetic alterations who have exhausted treatment options. Eligible participants must have a life expectancy over 3 months and no co-morbidities affecting risk. Erdafitinib is administered orally, starting at 8 mg daily, with potential dose increase based on serum phosphate levels and absence of toxicity.
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Program Overview
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.
Eligibility Criteria
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
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