A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

a study on Transitional Cell Carcinoma

Summary

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

Description

Summary

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)

Keywords

UC (Urothelial Cancer)Urothelial carcinomafibroblast growth factor (FGF)fibroblast growth factor receptor (FGFR)FGF/FGFR alterationsCarcinomaCarcinoma, Transitional Cellpemigatinib

Eligibility

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.

Locations

  • UCSF Helen Diller Family Comprehensive Care Center accepting new patients
    San FranciscoCalifornia94158United States
  • TRIO - Comprehensive Cancer Centers of Nevada accepting new patients
    Las VegasNevada89169-3321United States

Lead Scientist

  • Terence Friedlander
    I am a clinical and translational oncologist specializing in cancers of the genitourinary tract, specifically bladder and prostate cancers. My research is focused on understanding the basic biology these malignancies and in developing novel therapeutic ways to treat disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02872714
Phase
Phase 2
Study Type
Interventional
Last Updated