A phase II multicenter single arm study of oral BGJ398 in adult patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR genetic alterations who failed or are intolerant to platinum-based chemotherapy

Brief description of study

The purpose of this study is find out if the drug BGJ398 is safe and has beneficial effects in people who have advanced cholangiocarcinoma (biliary tract cancer). BGJ398 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. BGJ398 is an oral medication that is also known as an FGFR inhibitor. It belongs to a new class of medications called tyrosine kinase inhibitors. A tyrosine kinase inhibitor aims to block certain key protein structures (biological molecules) in or on the surface of your cells that are needed for the survival of cancer cells. These kind of drugs work to stop the cell growth of your cancer cells, which may even lead to your tumor being reduced in size.

Clinical Study Identifier: s19-00136
ClinicalTrials.gov Identifier: NCT02150967
Principal Investigator: Paul E. Oberstein.

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