Cholangiocarcinoma (Bile Duct Cancer)

Cholangiocarcinoma (CCA) affects approximately 8,000 to 10,000 individuals a year in the United States.11,12 FGFR genetic alterations are present in 25% of CCA cases.3 These include mutations, amplifications/deletions, and rearrangements/translocations, which sometimes result in fusion genes.13,14

In early clinical trials, infigratinib* has shown clinical activity in CCA with FGFR2 fusions.7 A single-arm, open-label, Phase 2 trial for infigratinib is being conducted in patients with advanced or metastatic CCA with FGFR2 gene fusions/translocations, or other FGFR genetic alterations who also:

  • Show evidence of radiologic progression following a gemcitabine + cisplatin regimen for advanced disease
OR
  • Have been treated with a gemcitabine-containing regimen, but cannot tolerate cisplatin

This trial remains open and is enrolling patients previously treated with an FGFR inhibitor, and patients with alterations other than FGFR2 fusions.

Amended Cohorts of the Second-line Trial

  • Cohort 1: patients with FGFR2 gene fusions or translocations
  • Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations
  • Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor
  • All patients will receive oral infigratinib, once daily, on a schedule of 3 weeks on (21 days), 1 week off (7 days). One treatment cycle consists of 28 days.

FGFR=fibroblast growth factor receptor.

Learn more about Phase 2, Second-line Clinical Trial for Cholangiocarcinoma, which is currently enrolling


  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.
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QED is currently enrolling for the PROOF Trial of infigratinib* for treatment of advanced/metastatic inoperable cholangiocarcinoma with FGFR2 fusions.


Learn more about Phase 3, First-line PROOF Trial for Cholangiocarcinoma, which is also currently enrolling


  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

References

  1. National Cancer Institute. https://www.cancer.gov/about-cancer/understanding/statistics. Updated April 27, 2018. Accessed January 7, 2020.
  2. Helsten T et al. Clin Cancer Res. 2016;22(1):259-267.
  3. Jain A et al. JCO Precis Oncol. doi:10.1200/PO.17.00080.
  4. Pellino A et al. Transl Gastroenterol Hepatol. 2018;3(7):1-15. doi:10.21037/tgh. 2018. 07.02.
  5. Knowles MA et al. Nat Rev Cancer. 2015;15(1):25-41.
  6. National Institutes of Health. https://ghr.nlm.nih.gov/gene/FGFR3. Published November 27, 2018. Accessed January 7, 2020.
  7. Javle M et al. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.
  8. National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02657486. Accessed January 7, 2020.
  9. National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02150967. Accessed January 7, 2020.
  10. Komla-Ebri D et al. J Clin Invest. 2016;126(5):1871-1884.
  1. American Cancer Society. https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html. Accessed January 7, 2020.
  2. Dana-Farber Cancer Institute. https://www.dana-farber.org/biliary-cancer/about/. Accessed January 7, 2020.
  3. Sia D et al. Nat Commun. 2015;6:6087. doi: 10.1038/ncomms7087.
  4. Griffiths AJF et al. https://www.ncbi.nlm.nih.gov/books/NBK21766/. Accessed January 7, 2020.
  5. Ross JS et al. Cancer. 2016;122(5):702-711.
  6. Sfakianos JP et al. Eur Urol. 2015;68(6):970-977.
  7. Moss TJ et al. Eur Urol. 2017;72(4):641-649.
  8. Bagrodia A et al. J Urol. 2016;195(6):1684-1689.
  9. Bagrodia A et al. Eur Urol Focus. 2019;5(3):365-368.
  10. Audenet F et al. Clin Cancer Res. 2019;25(3):967-976.
  11. National Institutes of Health. https://ghr.nlm.nih.gov/condition/achondroplasia. Accessed January 7, 2020.
  12. Legare JM et al. https://www.ncbi.nlm.nih.gov/books/NBK1152/. Accessed October 22, 2020.

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