Last updated on April 2019

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations


Are you eligible to participate in this study?

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

  • Conditions: Metastatic Cancer | Urothelial Tract Cancer
  • Age: 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy = 12 weeks.
  • Radiographically measurable or evaluable disease per RECIST v1.1.
  • Known FGF/FGFR alteration and have either (a) failed at least 1 previous treatment (ie, chemotherapy, immunotherapy) or (b) have not received chemotherapy due to insufficient renal function or poor ECOG performance for their metastatic or surgically unresectable urothelial carcinoma.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor.
  • 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.
  • Inability or unwillingness to swallow INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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