A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

UVA Tracking #
Principal Investigator
Paul R Kunk
Contact Phone
Official Trial Title
A phase 3, open-label, randomized study of futibatinib versus germcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced cholagiocarcinoma harboring FGFR2 gene rearrangements (FOENIX-CCA3)
Study Description

The University of Virginia is participating in a global clinical research study for adults ages 18 years of age, and over who have aberrations in FGF receptor (FGFR) genetic modification in cholangiocarcinoma (CCA). If you join this study, you may receive a new investigational drug named futibatinib (TAS-120). Gemcitabine-cisplatin chemotherapy, the control arm, is currently the first-line treatment for patients with advanced, metastatic, or recurrent unresectable intrahepatic CCA (iCCA) harboring FGFR2 gene rearrangements. This research study aims to evaluate the efficacy and safety of TAS-120 against that of the current standard of care (gemcitabine-cisplatin chemotherapy) in the first-line treatment of patients with locally advanced metastatic or recurrent unresectable intra-hepatic CCA (iCCA) harboring FGFR2 gene rearrangements.

You will be randomly assigned (like flipping a coin) to receive the study drug TAS 120- or Gemcitabine-cisplatin chemotherapy. Patients receiving the TAS-120 treatment will take TAS-120 tablets every day at home. Your study doctor will tell you how many tablets of study drug (TAS-120) you will need to take and how often you will need to take them. Patients receiving gemcitabine and cisplatin will have the medication administered in the study clinic for up to 6 months.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04093362



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