Primary Outcome
Open
Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1
Timeframe: Every 9 weeks throughout the study, up to approximately 6 months
Bladder Cancer
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Incyte Study ID:
INCB 54828-201
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Clinical Study 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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jan 2017 - Feb 2022
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion Criteria
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.
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.
Clinical Study Locations
Location
Status
Location
Arizona Oncology Associates (Wilmot)
Tucson, Arizona, US, 85711
Status
Completed
Location
Sharp Memorial Hospital
San Diego, California, US, 92123
Status
Completed
Location
UCSF Helen Diller Family Comprehensive Care Center
San Francisco, California, US, 94158
Status
Completed
Location
Rocky Mountain Cancer Centers
Boulder, Colorado, US, 80303
Status
Completed
Location
Calaway-Young Cancer Center at Valley View Hospital
Glenwood Springs, Colorado, US, 81601
Status
Completed
Location
Mount Sinai Medical Center
Miami Beach, Florida, US, 33140
Status
Completed
Protocol Summary
Incyte Study ID:
INCB 54828-201
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
263
Secondary Outcome
Open
Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events
Timeframe: From screening through 30-35 days after end of treatment, up to approximately 6 months
Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups
Timeframe: From screening through 30-35 days after end of treatment, up to approximately 6 months
Progression-free survival (PFS) based on RECIST v1.1
Timeframe: Every 9 weeks throughout the study, up to approximately 6 months
Duration of response
Timeframe: Every 9 weeks throughout the study, up to approximately 6 months