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

Primary Purpose

UC (Urothelial Cancer)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pemigatinib
pemigatinib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for UC (Urothelial Cancer) focused on measuring Urothelial carcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Oncology Associates (Wilmot)
  • Sharp Memorial Hospital
  • UCSF Helen Diller Family Comprehensive Care Center
  • Rocky Mountain Cancer Centers
  • Calaway-Young Cancer Center at Valley View Hospital
  • Mount Sinai Medical Center
  • Florida Hospital Cancer Institute
  • Emory University School of Medicine
  • University of Maryland, Greenebaum Cancer Center
  • Lahey Clinic Inc. - PARENT ACCOUNT
  • Minnesota Oncology Hematology, P.A.
  • GU Research Network
  • TRIO - Comprehensive Cancer Centers of Nevada
  • New York Oncology Hematology, P.C.
  • Northwell Cancer Institute
  • University of Rochester
  • University of North Carolina at Chapel Hill
  • Oncology Hematology Care, Inc.
  • Oregon Health & Science University
  • Compass Oncology the Northwest Cancer Specialists
  • St. Luke's Hospital
  • VA Pittsburgh Healthcare System
  • Carolina Urologic Research Center
  • Vanderbilt University Medical Center
  • Texas Oncology, P.A. - Austin
  • Texas Oncology - Baylor Charles A. Sammons
  • Texas Oncology
  • Texas Oncology, P.A. - Sherman
  • Baylor Scott & White Health
  • Huntsman Cancer Institute
  • Virginia Oncology Associates - Hampton
  • Northwest Medical Specialties, PLLC
  • University of Wisconsic Hospital and Clinic
  • Medical College of Wisconsin
  • UZ Antwerpen
  • AZ Sint-Lucas - Campus Sint-Lucas
  • AZ Groeninge Campus Loofstraat
  • AZ Delta
  • Rigshospitalet
  • CHU Besançon - Hôpital Jean Minjoz
  • Groupe Hospitalier Saint André - Hôpital Saint André
  • Institut Claudius Regaud-Oncopole
  • ICO - Site René Gauducheau
  • ICO - Site Paul Papin
  • Hopital Saint Louis
  • Centre Leon Berard
  • CHU Strasbourg - Nouvel Hôpital Civil
  • Groupe Hospitalier Pitie-Salpetriere
  • Institut Gustave Roussy
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Klinikum Dresden Standort Dresden-Friedrichstadt
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Universitaetsklinikum Hamburg-Eppendorf
  • Universitaetsklinikum Koeln
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitaetsklinikum Muenster
  • Studienpraxis Urologie Drs. Feyerabend
  • Universitaetsklinikum Tuebingen
  • Soroka University Medical Center
  • Assaf Harofeh Medical Center
  • Meir Medical Center
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
  • Ospedale degli Infermi
  • University Campus Bio-Medico di Roma
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • San Camillo-Forlanini Hospital
  • Kyushu University Hospital
  • Saitama Medical University International Medical Center
  • Hirosaki University Hospital
  • Teikyo University Hospital
  • Nihon University Itabashi Hospital
  • Nara Medical University Hospital
  • Osaka International Cancer Institute
  • Saitama Cancer Center
  • Osaka University Hospital
  • Jichi Medical University Hospital
  • VU Medisch Centrum
  • HagaZiekenhuis Van Den Haag
  • Zorgsaam Ziekenhuis
  • Viecuri Medisch Centrum
  • Clinica Universidad de Navarra
  • Hospital Universitari Vall d'Hebron
  • ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
  • Centro Integral Oncologico Clara Campal
  • University College London Hospitals
  • Guy's Hospital
  • Charing Cross Hospital
  • Nottingham University Hospitals City Campus
  • Beatson West of Scotland Cancer Centre
  • Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A-ID (Intermittent Dose) Pemigatinib

Cohort A-CD (Continuous Dose) Pemigatinib

Cohort B Pemigatinib

Arm Description

Pemigatinib in subjects with FGFR3 mutations or fusions.

Pemigatinib in subjects with FGFR3 mutations or fusions.

Pemigatinib in subjects with other FGF/FGFR alterations.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.

Secondary Outcome Measures

ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
ORR in Participants With All Other FGF/FGFR Alterations
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
Progression-free Survival (PFS)
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
Overall Survival
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.

Full Information

First Posted
August 16, 2016
Last Updated
February 28, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02872714
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
UC (Urothelial Cancer)
Keywords
Urothelial carcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A-ID (Intermittent Dose) Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib in subjects with FGFR3 mutations or fusions.
Arm Title
Cohort A-CD (Continuous Dose) Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib in subjects with FGFR3 mutations or fusions.
Arm Title
Cohort B Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib in subjects with other FGF/FGFR alterations.
Intervention Type
Drug
Intervention Name(s)
pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Intervention Type
Drug
Intervention Name(s)
pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
Pemigatinib once a day by mouth continuously.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
Description
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Time Frame
up to 1138 days
Secondary Outcome Measure Information:
Title
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Time Frame
up to 817 days
Title
ORR in Participants With All Other FGF/FGFR Alterations
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Time Frame
up to 1198 days
Title
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Time Frame
up to 1198 days
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
Time Frame
up to approximately 25 weeks
Title
Progression-free Survival (PFS)
Description
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Time Frame
up to 1138 days
Title
Duration of Response (DOR)
Description
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
Time Frame
up to 1075 days
Title
Overall Survival
Description
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.
Time Frame
up to 1610 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterine Asatiani, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates (Wilmot)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Care Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Calaway-Young Cancer Center at Valley View Hospital
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Maryland, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Lahey Clinic Inc. - PARENT ACCOUNT
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
TRIO - Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169-3321
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Northwell Cancer Institute
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97229
Country
United States
Facility Name
Compass Oncology the Northwest Cancer Specialists
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology, P.A. - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology, P.A. - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Oncology Associates - Hampton
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsic Hospital and Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Sint-Lucas - Campus Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge Campus Loofstraat
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besancon Cedex
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Groupe Hospitalier Saint André - Hôpital Saint André
City
Bordeaux cedex
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Claudius Regaud-Oncopole
City
Toulouse cedex 09
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
State/Province
Loire Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
ICO - Site Paul Papin
City
Angers Cedex 9
State/Province
Maine Et Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Saint Louis
City
Paris Cedex 10
State/Province
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 8
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
State/Province
Rhone
ZIP/Postal Code
67091
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Klinikum Dresden Standort Dresden-Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Studienpraxis Urologie Drs. Feyerabend
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Soroka University Medical Center
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428126
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52656
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo
City
Candiolo
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
University Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
San Camillo-Forlanini Hospital
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara-shi
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
HagaZiekenhuis Van Den Haag
City
Den Haag
Country
Netherlands
Facility Name
Zorgsaam Ziekenhuis
City
Terneuzen
ZIP/Postal Code
4535 PA
Country
Netherlands
Facility Name
Viecuri Medisch Centrum
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
University College London Hospitals
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Nottingham University Hospitals City Campus
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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