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

Janssen (J&J Innovative Medicine)

Status

Conditions: Advanced Cancers and FGFR Genetic Alterations

Treatments: Drug: Erdafitinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03825484

42756493MAF4001 (Other Identifier)

CR108489

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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