Trials / Completed
CompletedNCT02872714
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pemigatinib | Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy. |
| DRUG | pemigatinib | Pemigatinib once a day by mouth continuously. |
Timeline
- Start date
- 2017-01-12
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
- First posted
- 2016-08-19
- Last updated
- 2025-08-14
- Results posted
- 2023-03-24
Locations
96 sites across 11 countries: United States, Belgium, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02872714. Inclusion in this directory is not an endorsement.