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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410693
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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 FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Drug: Rogaratinib (BAY1163877) Drug: Chemotherapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : April 25, 2022
Estimated Study Completion Date : April 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rogaratinib

Rogaratinib treatment study arm, comprising

  1. Pre-treatment period, including FGFR testing and screening,
  2. Treatment period, and
  3. 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".
Drug: Rogaratinib (BAY1163877)
Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously

Active Comparator: Chemotherapy

Chemotherapy treatment study arm, comprising

  1. Pre-treatment period, including FGFR testing and screening,
  2. Treatment period, and
  3. 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".
Drug: Chemotherapy
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 in the given Country (i.e. the drug has to be approved at least for one indication in the given country).




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 45 months ]
    Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 45 months ]
    Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.

  2. Objective response rate (ORR) [ Time Frame: Up to 45 months ]
    Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.

  3. Disease-control rate (DCR) [ Time Frame: Up to 45 months ]
    Defined as the percentage of patients, whose overall best response was not progressive disease [PD] (i.e. CR, PR, Stable Disease [SD] or Non CR/Non PD). Tumor assessments with SD as response, that is performed prematurely after randomization of the patient (i.e. substantially earlier than the first planned radiological tumor assessment at 6 weeks), will not be taken into account.

  4. Duration of response (DOR) [ Time Frame: Up to 45 months ]
    Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.

  5. Incidence of Adverse Events as a measure of safety and tolerability [ Time Frame: Up to 45 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Existence of archival or fresh biopsy for FGFR testing
  • FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.

Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.

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

    • Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)
    • Locally advanced (T4b, 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 (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
  • 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 anti-cancer treatment within 4 weeks before randomization.
  • More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma
  • Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
  • 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)
  • Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization
  • Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410693


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Locations
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United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99503
United States, Arizona
Univeristy of Arizona Cancer Center
Phoenix, Arizona, United States, 85004
Arizona Oncology Associates, PC
Tucson, Arizona, United States, 85711
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
University of Southern California
Los Angeles, California, United States, 90033
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sansum Clinic
Santa Barbara, California, United States, 93105
United States, Colorado
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120-4413
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06510
United States, Florida
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503
United States, Illinois
Northwestern Medical Faculty Foundation Div Of Hem/Oncology
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Oregon
Compass Oncology
Tigard, Oregon, United States, 97223
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Bon Secours St. Francis Hospital
Greenville, South Carolina, United States, 29607
United States, South Dakota
Prairie Lakes Cancer Center
Watertown, South Dakota, United States, 57201
United States, Texas
Texas Oncology-Denton South
Denton, Texas, United States, 76210
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Houston Methodist Hospital
Houston, Texas, United States, 77030-2707
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Summit Cancer Center
Spokane, Washington, United States, 99208
Australia, New South Wales
Mid North Coast Cancer Institute
Coffs Harbour, New South Wales, Australia, 2450
Northern Cancer Institute
St Leonards, New South Wales, Australia, 2065
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia, 2650
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austria
Landesklinikum Krems
Krems, Austria, 3500
Krankenhaus der Barmherzigen Brüder
Wien, Austria, 1020
Allgemeines Krankenhaus der Stadt Wien
Wien, Austria, 1090
Wilhelminenspital der Stadt Wien
Wien, Austria, 1160
Belgium
UZ Gent
Gent, Belgium, 9000
CH de Jolimont - Lobbes Site de Jolimont
La Louviere, Belgium, 7100
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU de Liège
Liege, Belgium, 4000
Clinique Saint-Pierre
Ottignies, Belgium, 1340
Canada, Ontario
Princess Margaret Hospital-University Health Network
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada
Ottawa Hospital-General Campus
Ottawa, Canada, K1H 8L6
China, Fujian
FuJian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Hebei
The 2nd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Hubei
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
China, Hunan
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
China, Jiangsu
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, China, 210008
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Jiangxi
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Liaoning
Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, China, 110042
China, Shaanxi
The 1st Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
The first Hospital to AMU
Chongqing, Sichuan, China, 400038
China, Zhejiang
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
China
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Fifth Medical Center, General Hospital of the Chinese People
Beijing, China, 100071
Peking University Third Hospital
Beijing, China, 100191
Beijing Hospital
Beijing, China, 100730
Peking Union Medical College Hospital CAMS
Beijing, China, 100730
Chongqing Cancer Hospital
Chongqing, China, 400030
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Zhongshan Hospital, Fudan University
Shanghai, China, 200032
Huadong Hospital, Affiliated to Fudan University
Shanghai, China, 200040
Tianjin Medical University Cancer Institiute & Hospital
Tianjin, China, 300060
Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia, 708 52
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czechia, 10034
Fakultni Thomayerova Nemocnice
Praha 4 - Krc, Czechia, 140 59
Bata Hospital
Zlin, Czechia, 762 75
Denmark
Aarhus Universitetshospital, Skejby
Aarhus N, Denmark, 8200
Herlev Hospital
Herlev, Denmark, 2730
H:S Rigshospitalet
København, Denmark, 2100
Finland
Docrates Klinikka
Helsinki, Finland, 00180
France
Hopital Jean Minjoz
Besancon, France, 25030
Hôpital Saint André - Bordeaux
Bordeaux, France, 33000
Centre de Lutte Contre le Cancer François Baclesse
Caen Cedex 5, France, 14076
Centre Jean Perrin
Clermont Ferrand Cedex 1, France, 63011
Centre Oscar Lambret - Lille
Lille Cedex, France, 59020
Centre Léon Bérard
Lyon Cedex, France, 69008
Institut Paoli-Calmettes - Marseille
Marseille, France, 13273
Cochin - Paris
Paris, France, 75674
Hôpital d'Instruction des Armées Begin
Saint Mande, France, 94160
Clinique Saint Anne
Strasbourg, France, 67000
Centre Médico-Chirurgical Foch
Suresnes, France, 92151
Germany
Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89081
Universitätsklinikum Erlangen
Erlangen, Bayern, Germany, 91054
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen, Germany, 01307
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
Medizinische Fakultät der Otto-von-Guericke Universität
Magdeburg, Germany, 39120
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Hungary
MH Egeszsegugyi Kozpont
Budapest, Hungary, 1062
Bajcsy Zsilinszky Korhaz-Rendelointezet
Budapest, Hungary, 1106
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary, 7624
Ireland
Cork University Hospital
Cork, Ireland
AMNCH
Dublin, Ireland, 24
Israel
Rambam Health Corporation
Haifa, Israel, 3109601
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, Israel, 9112001
Meir Medical Center
Kfar Saba, Israel, 4428164
Rabin Medical Center - Beilinson Campus
Petah Tikva, Israel, 4941492
Chaim Sheba Medical Center
Ramat Gan, Israel, 5266202
Italy
IRST Istituto Scientifico Romagnolo per studio e cura tumori
Forlì-Cesena, Emilia-Romagna, Italy, 47014
AUSL Modena
Modena, Emilia-Romagna, Italy, 41012
A.O.U. di Modena - Policlinico
Modena, Emilia-Romagna, Italy, 41124
A.O. San Camillo-Forlanini
Roma, Lazio, Italy, 00152
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Lazio, Italy, 00168
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Lombardia, Italy, 20133
IRCCS Istituto Europeo di Oncologia (IEO)
Milano, Lombardia, Italy, 20141
ASST Grande Ospedale Metropolitano Niguarda
Milano, Lombardia, Italy, 20162
A.O.U. San Luigi Gonzaga
Torino, Piemonte, Italy, 10043
A.O.U. Pisana
Pisa, Toscana, Italy, 56126
A.O.U. Integrata Verona
Verona, Veneto, Italy, 37134
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Hirosaki University Hospital
Hirosaki, Aomori, Japan, 036-8563
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Gunma Prefectural Cancer Center
Ota, Gunma, Japan, 373-8550
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan, 060-8543
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Medical University Hospital
Morioka, Iwate, Japan, 028-3695
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Akita University Hospital
Akita, Japan, 010-8543
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Niigata University Medical and Dental Hospital
Niigata, Japan, 951-8520
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Tokushima University Hospital
Tokushima, Japan, 770-8503
Toyama University Hospital
Toyama, Japan, 930-0194
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggido, Korea, Republic of, 410-769
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Netherlands
Nederlands Kanker Instituut
Amsterdam, Netherlands, 1066 CX
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3075 EA
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Poland, 85-796
Swietokrzyskie Centrum Onkologii
Kielce, Poland, 25-734
Przychodnia Lekarska KOMED
Konin, Poland, 62-500
Salve Medica Sp. z o.o. SP.K.
Lodz, Poland, 91-211
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, Poland, 10-357
Szpital Kliniczny Przemienienia Panskiego
Poznan, Poland, 60-569
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, Poland, 50-556
Portugal
Hospital Beatriz Angelo
Loures, Lisboa, Portugal, 2674-514
CHUC - Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Instituto Português de Oncologia Francisco Gentil - Coimbra
Coimbra, Portugal, 3000-075
Hospital CUF Infante Santo
Lisboa, Portugal, 1350-070
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisboa, Portugal, 1649-035
CHUP, EPE - Hospital de Santo Antonio
Porto, Portugal, 4099-001
Russian Federation
Krasnoyarsk Regional Clinical Oncology Dispensary
Krasnoyarsk, Russian Federation, 660133
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
Moscow, Russian Federation, 125284
Urological Center POMC
Nizhny Novgorod, Russian Federation, 603109
Clinical Oncological Dispensary of Omsk Region
Omsk, Russian Federation, 644013
Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Bashkir State Medical University
Ufa, Russian Federation, 450008
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Center
Singapore, Singapore, 169610
Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia, 833 10
UROEXAM, spol. s r.o.
Nitra, Slovakia, 949 01
POKO Poprad s.r.o.
Poprad, Slovakia, 085 01
Spain
Hospital Reina Sofía
Córdoba, Andalucía, Spain, 14004
Institut Català d'Oncologia Badalona
Badalona, Barcelona, Spain, 08916
Institut Català d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital del Mar
Barcelona, Catalunya, Spain, 08003
Hospital Universitari Son Espases
Palma de Mallorca, Illes Baleares, Spain, 07120
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, Spain, 08035
Hospital San Pedro de Alcántara
Cáceres, Spain, 10003
MD Anderson International Espanya, S.A.
Madrid, Spain, 28033
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sweden
Södersjukhuset
Stockholm, Sweden, 118 83
Karolinska Institutet
Stockholm, Sweden, 17167
Norrlands Universitetssjukhus, Umeå
Umeå, Sweden, 901 85
Switzerland
Universitätsspital Basel
Basel, Basel-Stadt, Switzerland, 4031
Kantonsspital Graubünden
Chur, Graubünden, Switzerland, 7000
Kantonsspital St. Gallen
St. Gallen, Sankt Gallen, Switzerland, 9007
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan, 333
United Kingdom
Clatterbridge Centre for Oncology
Bebington, Merseyside, United Kingdom, CH63 4JY
Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03410693     History of Changes
Other Study ID Numbers: 17403
2016-004340-11 ( EudraCT Number )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Urothelial carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms