Last updated on July 2017

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy


Are you eligible to participate in this study?

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

  • Conditions: Liver Cancer
  • Age: 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically or cytologically confirmed cholangiocarcinoma.
  • Radiographically measurable disease per RECIST v1.1.
  • Documentation of FGF/FGFR gene alteration status.
  • Documented disease progression after at least 1 line of prior systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Life expectancy ≥ 12 weeks.
Exclusion Criteria:
  • Prior receipt of a selective FGFR inhibitor.
  • History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
  • Current evidence of clinically significant corneal or retinal disorder, confirmed by ophthalmologic examination.
  • Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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