Clinical trial NCT03390504: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
Official title: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urothelial Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

Detailed description: A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

Eligibility criteria: Inclusion Criteria:

* Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than \[\<\] 50 percent \[%\] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
* Metastatic or surgically unresectable urothelial cancer
* Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
* Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.
* A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at Screening (urine or serum)
* Participants must meet appropriate molecular eligibility criteria
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
* Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.
* Symptomatic central nervous system metastases
* Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
* Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
* Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
* History of uncontrolled cardiovascular disease
* Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
timeFrame: From randomization (3 days prior to Cycle 1 Day 1) until disease progression or relapse from CR or death (maximum up to 51.7 months)
measure: Objective Response Rate (ORR) Per RECIST Version 1.1
timeFrame: From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months
measure: Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)
timeFrame: Baseline up to Cycle 11 (each cycle was of 21 days)
measure: Time Until Symptom Deterioration
timeFrame: Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months
measure: Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS)
timeFrame: Baseline, 51.7 months
measure: Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)
timeFrame: Baseline up to Cycle 11 (each cycle was of 21 days)
measure: Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)
timeFrame: Baseline up to Cycle 11 (each cycle was of 21 days)
measure: Duration of Response (DOR) as Per RECIST Version 1.1
timeFrame: From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of the treatment (Day 1 Cycle 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (maximum up to 51.7 months)
measure: Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology
timeFrame: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)
measure: Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry
timeFrame: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)
measure: Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters
timeFrame: Day 1 of Cycle 2 and 4 (Each Cycle 21 days)
measure: Change From Baseline in Vital Signs: Weight
timeFrame: Baseline, 51.7 months
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test
timeFrame: From baseline up to maximum of 51.7 months
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity
timeFrame: From baseline up to maximum of 51.7 months
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid
timeFrame: From baseline up to maximum of 51.7 months
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation
timeFrame: From baseline up to maximum of 51.7 months
measure: Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment
timeFrame: From baseline up to maximum of 51.7 months
measure: Oral Clearance (CL/F) of Erdafitinib
timeFrame: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib
timeFrame: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Sacramento
country: United States
facility: University of Calif Davis Medical Center
state: California
city: Saint Helena
country: United States
facility: St. Helena Hospital - Martin-O'Neil Cancer Center
state: California
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Sylvester Cancer Center
state: Florida
city: Orange
country: United States
facility: Mid Florida Hematology Oncology
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr V A Hospital
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Lanham
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute, Carolinas HealthCare System
state: North Carolina
city: Salisbury
country: United States
facility: W G Bill Hefner VA Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology Tyler
state: Texas
city: Fairfax
country: United States
facility: INOVA Dwiight &Martha Schar Cancer Institute
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
city: Buenos Aires
country: Argentina
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Buenos Aires
country: Argentina
facility: Centro Oncológico Korben
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Viedma
country: Argentina
facility: Clínica Viedma
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
city: Kogarah
country: Australia
facility: St George Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Melbourne
country: Australia
facility: Frankston Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Vienna
country: Austria
facility: Medical University Vienna MUV
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: Clinique Notre Dame de Grâce
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Liege
country: Belgium
facility: CHC MontLegia
city: Wilrijk
country: Belgium
facility: Sint-Augustinus AZ
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Belo Horizonte
country: Brazil
facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Parana
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
city: Itajai
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao S A
city: Rio De Janeiro
country: Brazil
facility: Ministerio da Saude Instituto Nacional do Cancer
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo Andre
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: São Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
city: Sofia
country: Bulgaria
facility: UMHAT Sofia Med
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
city: Kelowna
country: Canada
facility: BC Cancer Agency - Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancercare Manitoba
state: Manitoba
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital- UHN
state: Ontario
city: Regina
country: Canada
facility: Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre
state: Saskatchewan
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Chengdu
country: China
facility: Sichuan University Huaxi Hospital
city: ChongQing
country: China
facility: Chongqing University Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Nanchang
country: China
facility: The First Affliated Hospital Of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: ShangHai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Shenzhen university General Hospital
city: Wenzhou
country: China
facility: First Affiliated Hospital Of Wenzhou Medical College
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Angers
country: France
facility: Institut de Cancerologie de l Ouest ICO
city: Besancon Cedex
country: France
facility: Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest
country: France
facility: CHRU Brest - Hopital Morvan
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lille
country: France
facility: Hôpital Privé Le Bois
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Groupe Hospitalier Bretagne Sud
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier Val d'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Institut de Cancérologie du Gard
city: Paris Cedex 10
country: France
facility: Hospital Saint-Louis
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon HCL
city: Poitiers Cedex
country: France
facility: CHU De Poitiers
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
city: Ris Orangis
country: France
facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de Loire
city: Strasbourg Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Valenciennes
country: France
facility: Centre Les Dentellieres
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carcus Dresden
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Erlangen
country: Germany
facility: Friedrich-Alexander Universitaet Urologische Universitaetskl
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Gottingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Lubeck
city: Mannheim
country: Germany
facility: Medizinische Fakultät Mannheim der Universität Heidelberg
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie Drs. Feyerabend
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Velbert
country: Germany
facility: MVZ-Onkologie Velbert GbR
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz AG/Klinikum Weiden
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center
city: Athens
country: Greece
facility: Athens Medical Center
city: Athens
country: Greece
facility: Metropolitan General A E
city: Athina
country: Greece
facility: University of Athens Medical School - Regional General Hospi
city: Larisa
country: Greece
facility: University Hospital Of Larissa
city: Patras
country: Greece
facility: University General Hospital of Rio Patras
city: Thessaloniki
country: Greece
facility: Interbalkan European Medical Center
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital Of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Korhaz
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
city: Arezzo
country: Italy
facility: Ospedale S. Donato - Asl 8 Arezzo
city: Aviano
country: Italy
facility: CRO IRCCS Istituto Nazionale Tumori
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona, AO di Cremona
city: Firenze
country: Italy
facility: Oncologia Medica
city: Genova
country: Italy
facility: SPDC Villa Scassi
city: Macerata
country: Italy
facility: UOC Oncologia Ospedale Provinciale di Macerata
city: Meldola
country: Italy
facility: IRST Meldola Forli
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Napoli
country: Italy
facility: IRCCS-Fondazione Pascale
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita
city: Orbassano
country: Italy
facility: Aou San Luigi Gonzaga
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Iov Irccs Padova
city: Parma
country: Italy
facility: AOU di Parma
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Poggibonsi (SI)
country: Italy
facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
city: Torino
country: Italy
facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino
city: Torrette Di Ancona
country: Italy
facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Kita Gun
country: Japan
facility: Kagawa University Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Matsuyama
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagano
country: Japan
facility: Nagano Municipal Hospital
city: Nagoya Shi
country: Japan
facility: Aichi Cancer Center Hospital
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Osaka-Sayama
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Ube
country: Japan
facility: Yamaguchi University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Aguascalientes
country: Mexico
facility: Medicos Especialistas en Cancer, S.C.
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerología de Chihuahua
city: Naucalpan
country: Mexico
facility: Oncologia Integral Satelite
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny we Wroclawiu
city: Lisboa
country: Portugal
facility: Hospital Lusíadas
city: Lisboa
country: Portugal
facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte
city: Lisboa
country: Portugal
facility: Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
city: Lisbon
country: Portugal
facility: Champalimaud Foundation Champalimaud Centre
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kostroma
country: Russian Federation
facility: Kostroma regional oncology dispensary
city: Kuzmolovsky
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. D.D.Pletnev
city: Moscow
country: Russian Federation
facility: FSBSI 'N. N. Blokhin Russian Cancer Research Center'
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Hertzen Oncology Research Institute
city: Nalchik
country: Russian Federation
facility: City Clinical Hospital #1
city: Nizhni Novgorod
country: Russian Federation
facility: Privolzhsky District Medical Center under the Federal Medico-Biological Agency
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: GBUZ of Stavropol region Pyatigorsk Oncological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Private Medical Institution Euromedservice
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: LLC 'Strategic Medical Systems'
city: Saint-Petersburg
country: Russian Federation
facility: Clinical hopital n/a Petra velikogo
city: Saransk
country: Russian Federation
facility: FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Smolensk
country: Russian Federation
facility: LLC Uromed
city: Sochi
country: Russian Federation
facility: GBUZ Oncology Centre #2 of Healthcare Department of Krasno
city: St. Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies
city: St.Petersburg
country: Russian Federation
facility: Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care
city: Tyumen
country: Russian Federation
facility: Multifunctional clinical medical center 'Medical city'
city: Ufa
country: Russian Federation
facility: Bashkiria State Medical University
city: Vologda
country: Russian Federation
facility: Vologda Regional Oncological Dispensary
city: Badajoz
country: Spain
facility: Hosp. Univ. Infanta Cristina
city: Badalona
country: Spain
facility: Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Caceres
country: Spain
facility: Hosp. San Pedro de Alcantara
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaen
city: Las Palmas de Gran Canaria
country: Spain
facility: Hosp. Univ. Insular de Gran Canaria
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Manresa
country: Spain
facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa
city: Pamplona
country: Spain
facility: Hosp. de Navarra
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Gral. Univ. Valencia
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Niao-Sung Hsiang
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Yong Kang
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Adana
country: Turkey
facility: Baskent University Adana Practice and Research Center Kisla Health Campus
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Bezmialem University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Training and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
city: Istanbul
country: Turkey
facility: T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov
city: Dnipro
country: Ukraine
facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
city: Kharkiv
country: Ukraine
facility: Municipal non-profit enterprise 'Regional Center of Oncology'
city: Kyiv
country: Ukraine
facility: National Cancer Institute
city: Kyiv
country: Ukraine
facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
city: Uzhgorod
country: Ukraine
facility: Transkarpathian Regional University Oncology Clinic
city: Vinnitsa
country: Ukraine
facility: Podilskiy Regional Center of Oncology
city: Zaporizhzhia
country: Ukraine
facility: Zaokod
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol - Bristol Haematology & Oncolog
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust Christie Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital-Department of Medical Oncology
city: Sheffield
country: United Kingdom
facility: University of Sheffield
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: