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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

May 31, 2018

Primary Completion Date

October 27, 2020

Study Completion Date

October 27, 2020

Conditions
Carcinoma, Transitional Cell
Interventions
DRUG

Rogaratinib (BAY1163877)

Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously

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 or treatment guidelines in the given country.

Trial Locations (161)

24

AMNCH, Dublin

704

National Cheng Kung University Hospital, Tainan City

1020

Krankenhaus der Barmherzigen Brüder, Vienna

1062

MH Egeszsegugyi Kozpont, Budapest

1090

Universitätsklinikum AKH Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

1160

Klinik Ottakring - Wilhelminenspital, Vienna

1340

Clinique Saint-Pierre, Ottignies

2065

Northern Cancer Institute, St Leonards

2076

Sydney Adventist Hospital, Wahroonga

2100

Rigshospitalet, Copenhagen

2109

Macquarie University Hospital, Sydney

2450

Mid North Coast Cancer Institute, Coffs Harbour

2650

Riverina Cancer Care Centre, Wagga Wagga

2730

Herlev Hospital - Oncology Research Dept., Herlev

3000

UZ Leuven Gasthuisberg, Leuven

3168

Monash Medical Centre, Clayton

3500

Landesklinikum Krems, Krems

4031

Universitätsspital Basel, Basel

4217

Pindara Private Hospital, Benowa

7000

Kantonsspital Graubünden, Chur

7624

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8200

Aarhus Universitetshospital, Skejby, Aarhus N

9000

UZ Gent, Ghent

9007

Kantonsspital St. Gallen, Sankt Gallen

10002

National Taiwan University Hospital, Taipei

10003

Hospital San Pedro de Alcántara, Cáceres

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

10043

A.O.U. San Luigi Gonzaga, Turin

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

13273

Institut Paoli-Calmettes - Marseille, Marseille

14004

Hospital Reina Sofía, Córdoba

14076

Centre de Lutte Contre le Cancer François Baclesse, Caen

15232

University of Pittsburgh, Pittsburgh

17167

Karolinska Institutet, Stockholm

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IRCCS Istituto Europeo di Oncologia s.r.l. (IEO), Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

25030

Hopital Jean Minjoz, Besançon

28034

Hospital Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Virgen de la Victoria, Málaga

29607

Bon Secours St. Francis Hospital, Greenville

32806

UF Cancer Center at Orlando Health, Orlando

33000

Hôpital Saint André - Bordeaux, Bordeaux

33305

Chang Gung Memorial Hospital at Linkou, Taoyuan District

37134

A.O.U.I. Verona, Verona

40225

Heinrich-Heine-Universität Düsseldorf, Düsseldorf

40705

Taichung Veterans General Hospital, Taichung

41012

AUSL Modena, Modena

41124

A.O.U. di Modena - Policlinico, Modena

46009

Instituto Valenciano de Oncología, Valencia

46014

Hospital General Universitario de Valencia, Valencia

47014

IRST Istituto Scientifico Romagnolo per studio e cura tumori, Forlì Cesena

55131

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

56126

A.O.U. Pisana, Pisa

59020

Centre Oscar Lambret - Lille, Lille

63011

Centre Jean Perrin, Clermont-Ferrand

66205

University of Kansas Medical Center, Westwood

67000

Clinique Saint Anne, Strasbourg

69008

Centre Léon Bérard, Lyon

72076

Eberhard-Karls-Universität Tübingen, Tübingen

75674

Cochin - Paris, Paris

76210

Texas Oncology-Denton South, Denton

85719

University of Arizona Cancer Center, Tucson

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

University of Southern California, Los Angeles

92151

Centre Médico-Chirurgical Foch, Suresnes

93105

Sansum Clinic, Santa Barbara

94160

Hôpital d'Instruction des Armées Begin, Saint-Mandé

95817

UC Davis Comprehensive Cancer Center, Sacramento

97223

Compass Oncology, Tigard

98101

Virginia Mason Medical Center, Seattle

99208

Summit Cancer Center, Spokane

99503

Alaska Clinical Research Center, LLC, Anchorage

100071

Fifth Medical Center, General Hospital of the Chinese People, Beijing

110042

Liaoning Cancer Hospital and Institute, Shengyang

119074

National University Hospital, Singapore

125284

Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen, Moscow

169610

National Cancer Center Singapore, Singapore

200032

Fudan University Shanghai Cancer Center, Shanghai

200040

Huadong Hospital, Affiliated to Fudan University, Shanghai

210008

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing

210009

Jiangsu Cancer Hospital, Nanjing

350001

FuJian Medical University Union Hospital, Fuzhou

430079

Hubei Cancer Hospital, Wuhan

450008

Bashkir State Medical University, Ufa

510060

Sun Yat-sen University Cancer Center, Guangzhou

603109

Volga District Med Center FMBA, Nizhny Novgorod

644013

Clinical Oncological Dispensary of Omsk Region, Omsk

660133

Krasnoyarsk Regional Clinical Oncology Dispensary, Krasnoyarsk

3109601

Rambam Health Corporation, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva

5266202

Chaim Sheba Medical Center, Ramat Gan

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

80120-4413

Rocky Mountain Cancer Centers, Littleton

77030-2707

Houston Methodist Hospital, Houston

M5G 2M9

Princess Margaret Hospital-University Health Network, Toronto

H3T 1E2

Sir Mortimer B. Davis Jewish General Hospital, Montreal

K1H 8L6

Ottawa Hospital-General Campus, Ottawa

Unknown

First Affiliated Hospital of Guangzhou Medical University, Guangzhou

Prince of Wales Hospital Hong Kong, Shatin

Cork University Hospital, Cork

708 52

Fakultni nemocnice Ostrava, Ostrava

140 59

Fakultni Thomayerova Nemocnice, Praha 4 - Krc

762 75

Bata Hospital, Zlín

00180

Docrates Klinikka, Helsinki

00152

A.O. San Camillo-Forlanini, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

466-8560

Nagoya University Hospital, Nagoya

036-8563

Hirosaki University Hospital, Hirosaki

371-8511

Gunma University Hospital, Maebashi

373-8550

Gunma Prefectural Cancer Center, Ōta

060-8543

Sapporo Medical University Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Kobe City Medical Center General Hospital, Kobe

305-8576

University of Tsukuba Hospital, Tsukuba

028-3695

Iwate Medical University Hospital, Morioka

236-0004

Yokohama City University Hospital, Yokohama

589-8511

Kindai University Hospital, Sayama

350-1298

Saitama Medical University International Medical Center, Hidaka

113-8603

Nippon Medical School Hospital, Bunkyo-ku

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

160-8582

Keio University Hospital, Shinjuku-ku

010-8543

Akita University Hospital, Akita

812-8582

Kyushu University Hospital, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

860-8556

Kumamoto University Hospital, Kumamoto

951-8520

Niigata University Medical and Dental Hospital, Niigata

541-8567

Osaka International Cancer Institute, Osaka

930-0194

Toyama University Hospital, Toyama

1066 CX

Nederlands Kanker Instituut, Amsterdam

3075 EA

Erasmus Medisch Centrum, Rotterdam

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka, Bydgoszcz

25-734

Swietokrzyskie Centrum Onkologii, Kielce

62-500

Przychodnia Lekarska KOMED, Konin

10-357

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn

60-569

Szpital Kliniczny Przemienienia Panskiego, Poznan

50-556

Uniwersytecki Szpital Kliniczny UM we Wroclawiu, Wroclaw

2674-514

Hospital Beatriz Angelo, Loures

3000-075

IPO Coimbra, Coimbra

1350-070

Hospital CUF Infante Santo, Lisbon

1649-035

CHULN - Hospital Santa Maria, Lisbon

4099-001

Centro Hospitalar Universitario do Porto, Porto

833 10

Narodny onkologicky ustav, Bratislava

949 01

UROEXAM, spol. s r.o., Nitra

085 01

POKO Poprad s.r.o., Poprad

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08916

Institut Català d'Oncologia Badalona, Badalona

08907

Institut Català d'Oncologia Hospitalet, L'Hospitalet de Llobregat

07120

Hospital Universitari Son Espases, Palma de Mallorca

08003

Hospital del Mar, Barcelona

08035

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona

118 83

Södersjukhuset, Stockholm

CH63 4JY

Clatterbridge Centre for Oncology, Bebington

SW3 6JJ

Royal Marsden Hospital (London), London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY