A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Trial Status: Active
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.
- 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.
- 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 Medical Center-Mount Zion
Emory University Hospital / Winship Cancer Institute
University of Maryland / Greenebaum Cancer Center
UNC Lineberger Comprehensive Cancer Center
OHSU Knight Cancer Institute
University of Pittsburgh Cancer Institute (UPCI)
Vanderbilt University / Ingram Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
University of Wisconsin Hospital and Clinics
Trial Phase Phase II
Trial Type Treatment
- Primary ID INCB 54828-201
- Secondary IDs NCI-2016-01513
- Clinicaltrials.gov ID NCT02872714