Janssen Scientific Affairs, LLC

Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Altera...

Official Title: 
Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options
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 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.
Approved for marketing
EA Type
Intermediate-size Population
Advanced Cancers and FGFR Genetic Alterations

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.
Other Name: JNJ-42756493

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

Eligibility Gender: 

Janssen Scientific Affairs, LLC Clinical Trial
Study Director
Janssen Scientific Affairs, LLC

Janssen Scientific Affairs, LLC
EA Number: 
MeSH Terms: 
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.