A Phase 3 Multicenter Open-Label Randomized Controlled Study of Oral Infigratinib versus Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations: The PROOF Trial

Brief description of study

The purpose of this study is to determine if the investigational drug, infigratinib, is an effective treatment for cholangiocarcinoma (bile duct cancer) compared with the standard of care, Gemcitabine with Cisplatin for patients with a genetic abnormality in the Fibroblast Growth Factor Receptor (FGFR) FGFR gene. Infigratinib is considered “investigational”, which means it has not been approved by the US Food & Drug Administration (FDA) for the treatment of people with your medical condition. Because of this, Infigratinib cannot be purchased.


Clinical Study Identifier: s19-00175
ClinicalTrials.gov Identifier: NCT03773302
Principal Investigator: Paul E. Oberstein.


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