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

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ClinicalTrials.gov Identifier: NCT02872714
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date April 25, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
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 ]
Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Overall response rate (ORR) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.
Change History Complete list of historical versions of study NCT02872714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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 ]
  • 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 ]
  • Progression-free survival (PFS) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    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
  • Duration of response [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • 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 ]
  • Progression-free survival (PFS) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    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
  • Duration of response [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE UC (Urothelial Cancer)
Intervention  ICMJE
  • Drug: pemigatinib
    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
    Other Name: INCB054828
  • Drug: pemigatinib
    Pemigatinib once a day by mouth continuously.
    Other Name: INCB054828
Study Arms  ICMJE
  • Experimental: Cohort A-ID (Intermittent Dose) Pemigatinib
    Pemigatinib in subjects with FGFR3 mutations or fusions.
    Intervention: Drug: pemigatinib
  • Experimental: Cohort A-CD (Continuous Dose) Pemigatinib
    Pemigatinib in subjects with FGFR3 mutations or fusions.
    Intervention: Drug: pemigatinib
  • Experimental: Cohort B Pemigatinib
    Pemigatinib in subjects with other FGF/FGFR alterations.
    Intervention: Drug: pemigatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
240
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
100
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center 1.855.463.3463
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02872714
Other Study ID Numbers  ICMJE INCB 54828-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ekaterine Asatiani, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP