Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A-ID (Intermittent Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
  • Drug: pemigatinib
    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
    Other names:
    • INCB054828
Experimental
Cohort A-CD (Continuous Dose) Pemigatinib
Pemigatinib in subjects with FGFR3 mutations or fusions.
  • Drug: pemigatinib
    Pemigatinib once a day by mouth continuously.
    Other names:
    • INCB054828
Experimental
Cohort B Pemigatinib
Pemigatinib in subjects with other FGF/FGFR alterations.
  • Drug: pemigatinib
    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
    Other names:
    • INCB054828

Recruiting Locations

University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Study Coordinator
410-328-8610

More Details

NCT ID
NCT02872714
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center
1.855.463.3463

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.