Clinical Trials /

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

NCT02872714

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-201
  • NCT ID: NCT02872714

Conditions

  • UC (Urothelial Cancer)

Interventions

DrugSynonymsArms
pemigatinibINCB054828Cohort A-ID (Intermittent Dose) Pemigatinib
pemigatinibINCB054828Cohort A-CD (Continuous Dose) Pemigatinib

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort A-ID (Intermittent Dose) PemigatinibExperimentalPemigatinib in subjects with FGFR3 mutations or fusions.
  • pemigatinib
Cohort A-CD (Continuous Dose) PemigatinibExperimentalPemigatinib in subjects with FGFR3 mutations or fusions.
  • pemigatinib
Cohort B PemigatinibExperimentalPemigatinib in subjects with other FGF/FGFR alterations.
  • pemigatinib

Eligibility 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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1
Time Frame:Every 9 weeks throughout the study, up to approximately 6 months
Safety Issue:
Description:Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.

Secondary Outcome Measures

Measure:Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events
Time Frame:From screening through 30-35 days after end of treatment, up to approximately 6 months
Safety Issue:
Description:
Measure:Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups
Time Frame:From screening through 30-35 days after end of treatment, up to approximately 6 months
Safety Issue:
Description:
Measure:Progression-free survival (PFS) based on RECIST v1.1
Time Frame:Every 9 weeks throughout the study, up to approximately 6 months
Safety Issue:
Description: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
Measure:Duration of response
Time Frame:Every 9 weeks throughout the study, up to approximately 6 months
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Urothelial carcinoma
  • fibroblast growth factor (FGF)
  • fibroblast growth factor receptor (FGFR)
  • FGF/FGFR alterations

Last Updated

October 6, 2020