At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 263 enrolled
Drug / intervention
pemigatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)
In Brief
A Phase 2 clinical trial evaluating pemigatinib for UC (Urothelial Cancer). Completed, enrolled 263 participants across 96 sites in 11 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUC (Urothelial Cancer)
CountriesBelgium, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartJan 2017
Primary CompletionFeb 2022
TodayJul 2026
First PostedAug 19, 2016
Enrollment StartJan 12, 2017
Primary CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.9 years ago
Interventions
pemigatinibdrug
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
pemigatinibdrug
Pemigatinib once a day by mouth continuously.