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NCT04087876 Clinical Trial

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

Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT04087876
Other study ID # DZB-iCCA-EA
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2023
Source Basilea Pharmaceutica
Contact Manuel Häckl, MD
Phone +41 76 302 53 10
Email manuel.haeckl@basilea.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• derazantinib
derazantinib will be administered orally

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Basilea Pharmaceutica
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