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 INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224154

Enrollment

263

Registered

2018-11-21

Start date

2018-10-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

UC (Urothelial Cancer)

Interventions

investigational material(s) Generic name etc : INCB054828 INN of investigational material : pemigatinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years and older in Japan 2) Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder. 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4) Life expectancy >=12 weeks. 5) Radiographically measurable per RECIST v1.1. 6) Documented FGF/FGFR alteration and have either a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.

Exclusion criteria

Exclusion criteria: 1) Prior receipt of a selective FGFR inhibitor. 2) 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. 3) Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.

Design outcomes

Primary

Measure	Time frame
efficacy Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1 Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.	—

Secondary

Measure	Time frame
safety efficacy 1. Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events 2. Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups 3. Progression-free survival (PFS) based on RECIST v1.1 Defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central radiographic review committee. 4. Duration of response Defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death.	—

Measure

Time frame

safety efficacy 1. Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events 2. Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups 3. Progression-free survival (PFS) based on RECIST v1.1 Defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central radiographic review committee. 4. Duration of response Defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death.

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Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026