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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Not Available
Phase II
Adults
Not Available
Not Available
Davis, Nancy
National
Vanderbilt University
01-11-2017
Treatment
VICCURO1668
NCT02872714

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

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.



Exclusion Criteria:

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.

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