A Study of Derazantinib in People with Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2-Related Genetic Changes

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Full Title

A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications (FIDES-01)

Purpose

The purpose of this study is to assess the safety and side effects of the investigational drug derazantinib in people with inoperable or advanced intrahepatic cholangiocarcinoma that persists despite treatment and contains a genetic change in the FGFR2 gene. The FGFR2 protein made by this gene is found on the surface of bile duct cells and other cells. Changes in FGFR2 are associated with several medical conditions, including intrahepatic cholangiocarcinoma.

Derazantinib works by blocking the FGFR2 protein, which may interrupt the communication pathway that causes cancer cells to multiply and spread. In this study, researchers want to see if the drug will be effective in people with a mutation (change) in the FGFR2 gene. Derazantinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic intrahepatic cholangiocarcinoma that continues to grow despite treatment.
  • Patients’ tumors must contain an FGFR2 mutation.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of the study drug.
  • Patients may not have previously received any FGFR inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Protocol

20-410

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators