A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma

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 INCB054828 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 INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Keywords

UC (Urothelial Cancer) Urothelial carcinoma fibroblast growth factor (FGF) fibroblast growth factor receptor (FGFR) FGF/FGFR alterations Carcinoma Carcinoma, Transitional Cell INCB054828

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 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 INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828.

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02872714
Phase
Phase 2
Lead Scientist
Terence Friedlander
Study Type
Interventional
Last Updated
January 15, 2018