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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 (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT03825484
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Janssen Scientific Affairs, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Scientific Affairs, LLC
    ClinicalTrials.gov Identifier:
    NCT03825484
    Other Study ID Numbers:
    • CR108489
    • 42756493MAF4001
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    May 13, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 13, 2019