Bladder Cancer

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

Incyte Study ID:
INCB 54828-201
CT.gov ID:
NCT02872714
View Results Summary
Eudra ID:
2016-001321-14
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study 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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Bladder Cancer
    • PRODUCT
  • Drug: pemigatinib
    • COLLABORATORS
    N/A
    DATE
    Jan 2017 - Feb 2022
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Arizona Oncology Associates (Wilmot)
    Tucson, Arizona, US, 85711
    Name
    Sharp Memorial Hospital
    San Diego, California, US, 92123
    Name
    UCSF Helen Diller Family Comprehensive Care Center
    San Francisco, California, US, 94158
    Name
    Rocky Mountain Cancer Centers
    Boulder, Colorado, US, 80303
    Name
    Calaway-Young Cancer Center at Valley View Hospital
    Glenwood Springs, Colorado, US, 81601
    Name
    Mount Sinai Medical Center
    Miami Beach, Florida, US, 33140
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    Key Inclusion and Exclusion 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.

    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.
    Requirements information
    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.

    Protocol Summary

    Incyte Study ID:
    INCB 54828-201
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: pemigatinib
    • Enrollment:
    263
    Primary Outcome
    Open

    Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1

    Timeframe: Every 9 weeks throughout the study, up to approximately 6 months

    Secondary Outcome
    Open

    Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events

    Timeframe: From screening through 30-35 days after end of treatment, up to approximately 6 months

    Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups

    Timeframe: From screening through 30-35 days after end of treatment, up to approximately 6 months

    Progression-free survival (PFS) based on RECIST v1.1

    Timeframe: Every 9 weeks throughout the study, up to approximately 6 months

    Duration of response

    Timeframe: Every 9 weeks throughout the study, up to approximately 6 months