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

Basilea Pharmaceutica

Status

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: derazantinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04087876

DZB-iCCA-EA

Details and patient eligibility

About

Basilea provided 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 was ongoing.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The following inclusion criteria were applied:

• all other treatment options had been exhausted
• patient was ineligible for any ongoing trials or was geographically inaccessible to trials including a trial with derazantinib
• there was a reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
• patient was willing and able to provide written informed consent
• if applicable, regulatory approval by the appropriate jurisdiction was obtained