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:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma
  • Official Title: 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

Clinical Trial IDs

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

Conditions

  • UC (Urothelial Cancer)

Interventions

DrugSynonymsArms
INCB054828Cohort A INCB054828

Purpose

The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Trial Arms

NameTypeDescriptionInterventions
Cohort A INCB054828ExperimentalINCB054828 in subjects with FGFR3 mutations or fusions
  • INCB054828
Cohort B INCB054828ExperimentalINCB054828 in subjects with other FGF/FGFR alterations
  • INCB054828

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically documented metastatic or surgically unresectable urothelial carcinoma;
             may include primary site from 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 INCB054828 or significant gastrointestinal
             disorder(s) that could interfere with the absorption, metabolism, or excretion of
             INCB054828.
      
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 INCB054828 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 INCB054828 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:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

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

Last Updated

January 15, 2018