for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Terence Friedlander
Headshot of Terence Friedlander
Terence Friedlander



The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Official Title

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)


UC (Urothelial Cancer) Urothelial carcinoma fibroblast growth factor (FGF) fibroblast growth factor receptor (FGFR) FGF/FGFR alterations Carcinoma Carcinoma, Transitional Cell pemigatinib


You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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 pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.


  • UCSF Helen Diller Family Comprehensive Care Center
    San Francisco California 94158 United States
  • TRIO - Comprehensive Cancer Centers of Nevada
    Las Vegas Nevada 89169-3321 United States

Lead Scientist at UCSF

  • Terence Friedlander
    I am a clinical and translational medical oncologist with a focused on urologic cancers, specifically cancers of the bladder, prostate, and kidney. I am also the Chief of the ZSFG Division of Hematology and Oncology. My research is focused on understanding the basic biology of urologic and other malignancies and in developing novel therapeutic ways to treat disease.


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 2
Study Type
Last Updated