Advanced Cancers and FGFR Genetic Alterations Clinical Trial
Official title:
Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options
| NCT number | NCT03825484 |
| Other study ID # | CR108489 |
| Secondary ID | 42756493MAF4001 |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | May 2019 |
| Source | Janssen Scientific Affairs, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Scientific Affairs, LLC |