Clinical trial · Interventional
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)
NCT02872714CI-TRIAL-00093626completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| UC (Urothelial Cancer) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemigatinib | Drug | Pemigatinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A-ID (Intermittent Dose) Pemigatinib
- description
- Pemigatinib in subjects with FGFR3 mutations or fusions.
- interventionNames
- Drug: pemigatinib
- type
- EXPERIMENTAL
- label
- Cohort A-CD (Continuous Dose) Pemigatinib
- description
- Pemigatinib in subjects with FGFR3 mutations or fusions.
- interventionNames
- Drug: pemigatinib
- type
- EXPERIMENTAL
- label
- Cohort B Pemigatinib
- description
- Pemigatinib in subjects with other FGF/FGFR alterations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDZhang C, Huang MN, Shan JQ, Hu ZJ, Li ZW, Liu JY. Pemigatinib, a selective FGFR inhibitor overcomes ABCB1-mediated multidrug resistance in cancer cells. Biochem Biophys Res Commun. 2024 Jan 8;691:149314. doi: 10.1016/j.bbrc.2023.149314. Epub 2023 Nov 24. PMID 38039831
- DERIVEDNecchi A, Pouessel D, Leibowitz R, Gupta S, Flechon A, Garcia-Donas J, Bilen MA, Debruyne PR, Milowsky MI, Friedlander T, Maio M, Gilmartin A, Li X, Veronese ML, Loriot Y. Pemigatinib for metastatic or surgically unresectable urothelial carcinoma with FGF/FGFR genomic alterations: final results from FIGHT-201. Ann Oncol. 2024 Feb;35(2):200-210. doi: 10.1016/j.annonc.2023.10.794. Epub 2023 Nov 11. PMID 37956738