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:
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Conditions: Metastatic Cancer | Urothelial Tract Cancer
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Age: 18 Years
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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.
