Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

Sponsor
Basilea Pharmaceutica (Industry)
Overall Status
Available
CT.gov ID
NCT04087876
Collaborator
(none)

Study Details

Study Description

Brief Summary

Basilea is providing expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib is ongoing.

Condition or DiseaseIntervention/TreatmentPhase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • all other treatment options have been exhausted

    • patient is ineligible for any ongoing trials or is geographically inaccessible to trials including an ongoing trial with derazantinib

    • there is reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product

    • patient is willing and able to provide written informed consent

    • if applicable, regulatory approval by the appropriate jurisdiction is obtained

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Basilea Pharmaceutica

    Investigators

    • Study Director: Miryana Dimova-Dobreva, MD, Basilea Pharmaceutica International Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Basilea Pharmaceutica
    ClinicalTrials.gov Identifier:
    NCT04087876
    Other Study ID Numbers:
    • DZB-iCCA-EA
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021

    Study Results

    No Results Posted as of Jun 18, 2021