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 Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: derazantinib

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