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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Cholangiocarcinoma
    Inoperable Cholangiocarinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Have histologically or cytologically confirmed non-resectable, recurrent, or metastatic cholangiocarcinoma. Subjects with gallbladder cancer or ampulla of Vater carcinoma are not eligible. 2) Have written documentation of local or central laboratory determination of FGFR2 gene fusions/translocations. Note: Central confirmation is not required prior to enrollment in study. 3) Have a representative tumor sample available for central FGFR2 fusion/translocation molecular testing. An archival tumor sample and associated pathology report may be submitted. However, if not available, a newly obtained tumor biopsy may be submitted instead. Note: If available FGFR2 fusion/translocation written documentation is from the central laboratory being used in the study, a tumor sample does not need to be submitted for central FGFR2 fusion/translocation molecular testing. 4) Are able to swallow and retain oral medication. 5) Are willing and able to comply with scheduled visits, treatment plan and laboratory tests.

You may not be eligible for this study if the following are true:

  • 1) Have received treatment with any systemic anti-cancer therapy for unresectable, recurrent, or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted if completed >6 months prior to first dose of study drug. 2) Have history of a liver transplant. 3) Have received prior or current treatment with a MEK or selective FGFR inhibitor. 4) Have neurological symptoms related to underlying disease requiring increasing doses of corticosteroids. Note: Steroid use for management of central nervous system tumors is allowed but must be at a stable dose for at least 2 weeks preceding study entry.


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