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Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)

Primary Purpose

Carcinoma, Transitional Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rogaratinib (BAY1163877)
Chemotherapy
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell focused on measuring Urothelial carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment.

  • Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria

    • Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.)
    • Locally advanced (T4, any N; or any T, N 2-3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
  • Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.
  • High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual
  • At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI

Exclusion Criteria:

  • Previous or concurrent cancer except

    • cervical carcinoma in situ
    • treated basal-cell or squamous cell skin carcinoma
    • any cancer curatively treated > 3 years before randomization
    • curatively treated incidental prostate cancer (T1/T2a)
  • Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine
  • More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease
  • Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
  • Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism

  • History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:

    • Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
    • Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
    • Myocardial infarction (MI) within past 6 months before randomization
    • Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
  • Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
  • Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
  • Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
  • Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization

Sites / Locations

  • Alaska Clinical Research Center, LLC
  • University of Arizona Cancer Center
  • University of Southern California
  • UC Davis Comprehensive Cancer Center
  • Sansum Clinic
  • Rocky Mountain Cancer Centers
  • UF Cancer Center at Orlando Health
  • University of Kansas Medical Center
  • Comprehensive Cancer Centers of Nevada
  • Compass Oncology
  • University of Pittsburgh
  • Bon Secours St. Francis Hospital
  • Texas Oncology-Denton South
  • Houston Methodist Hospital
  • Virginia Mason Medical Center
  • Summit Cancer Center
  • Mid North Coast Cancer Institute
  • Northern Cancer Institute
  • Macquarie University Hospital
  • Riverina Cancer Care Centre
  • Sydney Adventist Hospital
  • Pindara Private Hospital
  • Monash Medical Centre
  • Landesklinikum Krems
  • Krankenhaus der Barmherzigen Brüder
  • Universitätsklinikum AKH Wien
  • Klinik Ottakring - Wilhelminenspital
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • Clinique Saint-Pierre
  • Princess Margaret Hospital-University Health Network
  • Sir Mortimer B. Davis Jewish General Hospital
  • Ottawa Hospital-General Campus
  • FuJian Medical University Union Hospital
  • Sun Yat-sen University Cancer Center
  • Hubei Cancer Hospital
  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
  • Jiangsu Cancer Hospital
  • Liaoning Cancer Hospital and Institute
  • Fifth Medical Center, General Hospital of the Chinese People
  • First Affiliated Hospital of Guangzhou Medical University
  • Fudan University Shanghai Cancer Center
  • Huadong Hospital, Affiliated to Fudan University
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni Thomayerova Nemocnice
  • Bata Hospital
  • Aarhus Universitetshospital, Skejby
  • Herlev Hospital - Oncology Research Dept.
  • Rigshospitalet
  • Docrates Klinikka
  • Hopital Jean Minjoz
  • Hôpital Saint André - Bordeaux
  • Centre de Lutte Contre le Cancer François Baclesse
  • Centre Jean Perrin
  • Centre Oscar Lambret - Lille
  • Centre Léon Bérard
  • Institut Paoli-Calmettes - Marseille
  • Cochin - Paris
  • Hôpital d'Instruction des Armées Begin
  • Clinique Saint Anne
  • Centre Médico-Chirurgical Foch
  • Eberhard-Karls-Universität Tübingen
  • Heinrich-Heine-Universität Düsseldorf
  • Universitätsmedizin der Johannes Gutenberg Universität Mainz
  • Prince of Wales Hospital Hong Kong
  • MH Egeszsegugyi Kozpont
  • Orszagos Onkologiai Intezet
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Cork University Hospital
  • AMNCH
  • Rambam Health Corporation
  • Hadassah Hebrew University Hospital Ein Kerem
  • Meir Medical Center
  • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center
  • IRST Istituto Scientifico Romagnolo per studio e cura tumori
  • AUSL Modena
  • A.O.U. di Modena - Policlinico
  • A.O. San Camillo-Forlanini
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
  • ASST Grande Ospedale Metropolitano Niguarda
  • A.O.U. San Luigi Gonzaga
  • A.O.U. Pisana
  • A.O.U.I. Verona
  • Nagoya University Hospital
  • Hirosaki University Hospital
  • Gunma University Hospital
  • Gunma Prefectural Cancer Center
  • Sapporo Medical University Hospital
  • Hokkaido University Hospital
  • Kobe City Medical Center General Hospital
  • University of Tsukuba Hospital
  • Iwate Medical University Hospital
  • Yokohama City University Hospital
  • Kindai University Hospital
  • Saitama Medical University International Medical Center
  • Nippon Medical School Hospital
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Keio University Hospital
  • Akita University Hospital
  • Kyushu University Hospital
  • Hiroshima City Hiroshima Citizens Hospital
  • Kumamoto University Hospital
  • Niigata University Medical and Dental Hospital
  • Osaka International Cancer Institute
  • Toyama University Hospital
  • National Cancer Center
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Nederlands Kanker Instituut
  • Erasmus Medisch Centrum
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
  • Swietokrzyskie Centrum Onkologii
  • Przychodnia Lekarska KOMED
  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
  • Szpital Kliniczny Przemienienia Panskiego
  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
  • Hospital Beatriz Angelo
  • IPO Coimbra
  • Hospital CUF Infante Santo
  • CHULN - Hospital Santa Maria
  • Centro Hospitalar Universitario do Porto
  • Krasnoyarsk Regional Clinical Oncology Dispensary
  • Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
  • Volga District Med Center FMBA
  • Clinical Oncological Dispensary of Omsk Region
  • Bashkir State Medical University
  • National University Hospital
  • National Cancer Center Singapore
  • Narodny onkologicky ustav
  • UROEXAM, spol. s r.o.
  • POKO Poprad s.r.o.
  • Institut Català d'Oncologia Badalona
  • Institut Català d'Oncologia Hospitalet
  • Hospital Universitari Son Espases
  • Hospital del Mar
  • Ciutat Sanitària i Universitaria de la Vall d'Hebron
  • Hospital San Pedro de Alcántara
  • Hospital Reina Sofía
  • Hospital Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Virgen de la Victoria
  • Instituto Valenciano de Oncología
  • Hospital General Universitario de Valencia
  • Södersjukhuset
  • Karolinska Institutet
  • Universitätsspital Basel
  • Kantonsspital Graubünden
  • Kantonsspital St. Gallen
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital at Linkou
  • Clatterbridge Centre for Oncology
  • Royal Marsden Hospital (London)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rogaratinib

Chemotherapy

Arm Description

Rogaratinib treatment study arm, comprising Pre-treatment period, including FGFR testing and screening, Treatment period, and Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".

Chemotherapy treatment study arm, comprising Pre-treatment period, including FGFR testing and screening, Treatment period, and Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) - Central Assessment
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.

Secondary Outcome Measures

Disease-control Rate (DCR) - Central Assessment
DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).
Progression-free Survival (PFS) - Central Assessment
Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).
Duration of Response (DOR) - Central Assessment
DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier
Number of Participants With Treatment Emergent Adverse Events
A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment

Full Information

First Posted
January 19, 2018
Last Updated
September 25, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03410693
Brief Title
Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
Acronym
FORT-1
Official Title
A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
October 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

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

5. Study Description

Brief Summary
This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Transitional Cell
Keywords
Urothelial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rogaratinib
Arm Type
Experimental
Arm Description
Rogaratinib treatment study arm, comprising Pre-treatment period, including FGFR testing and screening, Treatment period, and Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy treatment study arm, comprising Pre-treatment period, including FGFR testing and screening, Treatment period, and Follow-up period, including active follow-up and long-term follow-up. Patients will be considered "on study" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered "off study".
Intervention Type
Drug
Intervention Name(s)
Rogaratinib (BAY1163877)
Intervention Description
Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization or treatment guidelines in the given country.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) - Central Assessment
Description
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.
Time Frame
From start of treatment up to end of active follow-up, approximately 29 months
Secondary Outcome Measure Information:
Title
Disease-control Rate (DCR) - Central Assessment
Description
DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).
Time Frame
From start of treatment till end of active follow-up, approximately 29 months
Title
Progression-free Survival (PFS) - Central Assessment
Description
Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).
Time Frame
From start of treatment till end of active follow-up, approximately 29 months
Title
Duration of Response (DOR) - Central Assessment
Description
DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier
Time Frame
From start of treatment till end of active follow-up, approximately 29 months
Title
Number of Participants With Treatment Emergent Adverse Events
Description
A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment
Time Frame
From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment. Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.) Locally advanced (T4, any N; or any T, N 2-3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3). ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1 Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment. High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI Exclusion Criteria: Previous or concurrent cancer except cervical carcinoma in situ treated basal-cell or squamous cell skin carcinoma any cancer curatively treated > 3 years before randomization curatively treated incidental prostate cancer (T1/T2a) Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease Ongoing or previous anti-cancer treatment within 4 weeks before randomization. Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2 Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization) Myocardial infarction (MI) within past 6 months before randomization Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible. Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia) Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4413
Country
United States
Facility Name
UF Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Compass Oncology
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Bon Secours St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Texas Oncology-Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2707
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Summit Cancer Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Mid North Coast Cancer Institute
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Northern Cancer Institute
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Macquarie University Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Landesklinikum Krems
City
Krems
ZIP/Postal Code
3500
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Ottakring - Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique Saint-Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Princess Margaret Hospital-University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Ottawa Hospital-General Campus
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
FuJian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Liaoning Cancer Hospital and Institute
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Fifth Medical Center, General Hospital of the Chinese People
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huadong Hospital, Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Fakultni Thomayerova Nemocnice
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Bata Hospital
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herlev Hospital - Oncology Research Dept.
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Docrates Klinikka
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Saint André - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre de Lutte Contre le Cancer François Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Oscar Lambret - Lille
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli-Calmettes - Marseille
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Cochin - Paris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital d'Instruction des Armées Begin
City
Saint Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Clinique Saint Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Médico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Eberhard-Karls-Universität Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Prince of Wales Hospital Hong Kong
City
Shatin
Country
Hong Kong
Facility Name
MH Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
AMNCH
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
IRST Istituto Scientifico Romagnolo per studio e cura tumori
City
Forlì Cesena
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
AUSL Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41012
Country
Italy
Facility Name
A.O.U. di Modena - Policlinico
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O. San Camillo-Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Nederlands Kanker Instituut
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Przychodnia Lekarska KOMED
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital Beatriz Angelo
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
IPO Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital CUF Infante Santo
City
Lisboa
ZIP/Postal Code
1350-070
Country
Portugal
Facility Name
CHULN - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Krasnoyarsk Regional Clinical Oncology Dispensary
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Volga District Med Center FMBA
City
Nizhny Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
Clinical Oncological Dispensary of Omsk Region
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
UROEXAM, spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
POKO Poprad s.r.o.
City
Poprad
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Institut Català d'Oncologia Badalona
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Institut Català d'Oncologia Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Illes Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Ciutat Sanitària i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17167
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Clatterbridge Centre for Oncology
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Royal Marsden Hospital (London)
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36240478
Citation
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, Garcia Del Muro X, Joly F, Papai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2023 Jan 20;41(3):629-639. doi: 10.1200/JCO.21.02303. Epub 2022 Oct 14.
Results Reference
derived
PubMed Identifier
30807645
Citation
Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

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