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PROOF Trial: Investigational new drug for the treatment of bile duct cancer

COVID-19 update:

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.

Trial ID:
IRB-19-7395
Darren Sigal, M.D.
This study is comparing an investigational oral drug called infigratinib to the standard treatment for patients with cholangiocarcinoma.

Inclusion Criteria

  • 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

Exclusion Criteria

  • Have received prior systemic treatment for cholangiocarcinoma
  • Have a corneal or retinal disorder
  • Have a gastrointestinal disease or impairment of gastrointestinal function

Additional Info

  • 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.

Contact Info:

  • Gail Moore, RN
  • moore.gail@scrippshealth.org