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

Sponsor: Basilea Pharmaceutica

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04087876

Patient View

Basilea offers expanded access to derazantinib for patients with advanced iCCA with FGFR alterations who have exhausted other treatments and cannot join ongoing trials. Eligibility requires informed consent and potential benefit outweighing risks. Derazantinib is administered orally, subject to regulatory approval if needed.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

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