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

Completed · Phase 2

Conditions studied: UC (Urothelial Cancer)

In brief

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.

Key facts

Study ID

NCT02872714

Run by

Incyte Corporation

People needed

263

Starts

2017-01-12

Expected to finish

2022-02-01

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• UCSF Helen Diller Family Comprehensive Care Center — San Francisco, California, United States
• Rocky Mountain Cancer Centers — Boulder, Colorado, United States
• Calaway-Young Cancer Center at Valley View Hospital — Glenwood Springs, Colorado, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Maryland, Greenebaum Cancer Center — Baltimore, Maryland, United States
• Lahey Clinic Inc. - PARENT ACCOUNT — Burlington, Massachusetts, United States
• Minnesota Oncology Hematology, P.A. — Woodbury, Minnesota, United States
• GU Research Network — Omaha, Nebraska, United States
• TRIO - Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Northwell Cancer Institute — New Hyde Park, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Compass Oncology the Northwest Cancer Specialists — Tualatin, Oregon, United States
• St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology, P.A. - Austin — Austin, Texas, United States
• Arizona Oncology Associates (Wilmot) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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