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PROOF Trial: Investigational new drug for the treatment of bile duct cancer
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
Darren Sigal, M.D.
This study is comparing an investigational oral drug called infigratinib to the standard treatment for patients with cholangiocarcinoma.
Have non-resectable, recurrent, or metastatic cholangiocarcinoma
Have documented FGFR2 gene fusions/translocations
Be at least 18 years of age
Be able to return to the clinic for study visits
Have received prior systemic treatment for cholangiocarcinoma
Have a corneal or retinal disorder
Have a gastrointestinal disease or impairment of gastrointestinal function
Eligible patients will be randomized 1:1, like the flip of coin, to received either standard treatment plus the investigational drug or standard treatment alone.