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Brief Title: Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

INTRODUCTION

  • Org Study ID: CR108401
  • Secondary ID: 2017-002932-18, 42756493BLC3001
  • NTC ID: NCT03390504
  • Sponsor: Janssen Research & Development, LLC
To learn how to participate in this trial please click here.

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, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

  • Overall Status
    Recruiting
  • Start Date
    March 23, 2018
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Survival (OS)

Primary Outcome 1 - Timeframe: Date of first randomization to the date of participant's death (approximately up to 3 years)

CONDITION

  • Urothelial Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

LOCATION

Facility Status Contact
Facility: University of Calif Davis Medical Center
Sacramento, California 95817
United States
Status: Recruiting Contact: N/A
Facility: MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: N/A
Facility: University of Miami/Sylvester Cancer Center
Miami, Florida 33136
United States
Status: Recruiting Contact: N/A
Facility: Rush University
Chicago, Illinois 60612
United States
Status: Recruiting Contact: N/A
Facility: Edward Hines Jr V A Hospital
Hines, Illinois 60141
United States
Status: Recruiting Contact: N/A
Facility: Norton Cancer Institute
Louisville, Kentucky 40207
United States
Status: Recruiting Contact: N/A
Facility: Maryland Oncology Hematology, PA
Lanham, Maryland 20706
United States
Status: Recruiting Contact: N/A
Facility: VA Sierra Nevada Health Care System
Reno, Nevada 89509
United States
Status: Recruiting Contact: N/A
Facility: Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Status: Recruiting Contact: N/A
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: N/A
Facility: Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: N/A
Facility: The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Memorial City
Houston, Texas 77024
United States
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Texas Oncology-Tyler
Tyler, Texas 75702
United States
Status: Recruiting Contact: N/A
Facility: INOVA Dwiight &Martha Schar Cancer Institute
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: N/A
Facility: Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Status: Recruiting Contact: N/A
Facility: Hospital Sirio Libanes
Buenos Aires, British Columbia C1419AHN
Argentina
Status: Recruiting Contact: N/A
Facility: CEMIC Saavedra
Ciudad Autonoma de Buenos Aires, Manitoba C1431FWN
Argentina
Status: Recruiting Contact: N/A
Facility: Centro Oncológico Korben
Ciudad Autónoma de Buenos Aires, Ontario C1426AGE
Argentina
Status: Recruiting Contact: N/A
Facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba, Ontario C5000
Argentina
Status: Recruiting Contact: N/A
Facility: Centro Urologico Profesor Bengio
Cordoba, Saskatchewan X5000KPH
Argentina
Status: Recruiting Contact: N/A
Facility: Hospital Privado de Comunidad
Mar Del Plata, B7602CBM
Argentina
Status: Recruiting Contact: N/A
Facility: Centro de Investigacion Pergamino SA
Pergamino, B2700CPM
Argentina
Status: Recruiting Contact: N/A
Facility: Clínica Viedma
Viedma, R8500ACE
Argentina
Status: Recruiting Contact: N/A
Facility: Chris O'Brien Lifehouse
Camperdown, 2050
Australia
Status: Recruiting Contact: N/A
Facility: Peninsula & South Eastern Haematology and Oncology Group
Frankston, 3199
Australia
Status: Recruiting Contact: N/A
Facility: St George Hospital
Kogarah, 2217
Australia
Status: Recruiting Contact: N/A
Facility: Peter MacCallum Cancer Centre
Melbourne, 3000
Australia
Status: Recruiting Contact: N/A
Facility: Frankston Hospital
Melbourne, 3199
Australia
Status: Recruiting Contact: N/A
Facility: Fiona Stanley Hospital
Murdoch, 6150
Australia
Status: Recruiting Contact: N/A
Facility: LKH-Univ. Klinikum Graz
Graz, 8036
Austria
Status: Recruiting Contact: N/A
Facility: Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Austria
Status: Recruiting Contact: N/A
Facility: LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020
Austria
Status: Recruiting Contact: N/A
Facility: Medical University Vienna, MUV
Vienna, A-1090
Austria
Status: Recruiting Contact: N/A
Facility: OLV Ziekenhuis Aalst
Aalst, 9300
Belgium
Status: Recruiting Contact: N/A
Facility: ZNA Middelheim
Antwerpen, 2020
Belgium
Status: Recruiting Contact: N/A
Facility: Cliniques Universitaires Saint-Luc
Brussel, 1200
Belgium
Status: Recruiting Contact: N/A
Facility: Clinique Notre Dame de Grâce
Charleroi, 6000
Belgium
Status: Recruiting Contact: N/A
Facility: AZ Maria Middelares
Gent, 9000
Belgium
Status: Recruiting Contact: N/A
Facility: UZ Gent
Gent, 9000
Belgium
Status: Recruiting Contact: N/A
Facility: CHC MontLegia
Liege, 4000
Belgium
Status: Recruiting Contact: N/A
Facility: CHU UCL Namur - Site Godinne
Yvoir, 5530
Belgium
Status: Recruiting Contact: N/A
Facility: Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos, 14784-400
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais
Belo Horizonte, 30130-100
Brazil
Status: Recruiting Contact: N/A
Facility: Associação Mário Penna/Núcleo de Ensino e Pesquisas
Belo Horizonte, 30380-472
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Erasto Gaertner
Curitiba, 81520-060
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás
Goiânia, 74605-070
Brazil
Status: Recruiting Contact: N/A
Facility: Clínica de Neoplasias Litoral Ltda.
Itajai, 88301-220
Brazil
Status: Recruiting Contact: N/A
Facility: Centro de Pesquisas do Hospital Amaral Carvalho
Jaú, 17210-080
Brazil
Status: Recruiting Contact: N/A
Facility: Liga Norte Riograndense Contra O Cancer
Natal, 59075-740
Brazil
Status: Recruiting Contact: N/A
Facility: Upco - Hcpa
Porto Alegre, 90035-903
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Conceicao
Porto Alegre, 91410-330
Brazil
Status: Recruiting Contact: N/A
Facility: INCA - Instituto Nacional Do Cancer
Rio de Janeiro, 20231-050
Brazil
Status: Recruiting Contact: N/A
Facility: Oncoclínicas
Rio De Janeiro, 22250-905
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Sao Rafael
Salvador, 41253-190
Brazil
Status: Recruiting Contact: N/A
Facility: Fundacao Antonio Prudente
Sao Paulo, 01509900
Brazil
Status: Recruiting Contact: N/A
Facility: Ibcc - Instituto Brasileiro de Controle Do Cancer
Sao Paulo, 18030-005
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
Sorocaba, 15090-000
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital de Base de São José do Rio Preto
São José do Rio Preto, 01308901
Brazil
Status: Recruiting Contact: N/A
Facility: Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes
São Paulo, 04502-001
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 05651-900
Brazil
Status: Recruiting Contact: N/A
Facility: CEPHO - Faculdade de Medicina do ABC
São Paulo, 5800
Brazil
Status: Recruiting Contact: N/A
Facility: BC Cancer Agency - Southern Interior
Kelowna, V5Z 4E6
Canada
Status: Recruiting Contact: N/A
Facility: Vancouver Cancer Centre
Vancouver, R3E 0V9
Canada
Status: Recruiting Contact: N/A
Facility: Cancercare Manitoba
Winnipeg, P7B 6V4
Canada
Status: Recruiting Contact: N/A
Facility: Thunder Bay Regional Health Sciences Centre
Thunder Bay, M5G 2M9
Canada
Status: Recruiting Contact: N/A
Facility: Princess Margaret Hospital- UHN
Toronto, S4T 7T1
Canada
Status: Recruiting Contact: N/A
Facility: Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre
Regina, 100021
Canada
Status: Recruiting Contact: N/A
Facility: Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100034
China
Status: Recruiting Contact: N/A
Facility: Peking University First Hospital
Beijing, 100050
China
Status: Recruiting Contact: N/A
Facility: Beijing Friendship Hospital
Beijing, 100191
China
Status: Recruiting Contact: N/A
Facility: Peking University Third Hospital
Beijing, 100730
China
Status: Recruiting Contact: N/A
Facility: Beijing Hospital
BeiJing, 100730
China
Status: Recruiting Contact: N/A
Facility: Peking Union Medical College Hospital
Beijing, 130021
China
Status: Recruiting Contact: N/A
Facility: Sichuan Provincial People's Hospital
Chengdu, 610041
China
Status: Recruiting Contact: N/A
Facility: Sichuan University Huaxi Hospital
Chengdu, 400030
China
Status: Recruiting Contact: N/A
Facility: Chongqing University Cancer Hospital
ChongQing, 510060
China
Status: Recruiting Contact: N/A
Facility: Sun Yat-Sen University Cancer Center
Guangzhou, 510120
China
Status: Recruiting Contact: N/A
Facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510180
China
Status: Recruiting Contact: N/A
Facility: Guangzhou First Municipal People's Hospital
Guangzhou, 310014
China
Status: Recruiting Contact: N/A
Facility: Zhejiang Provincial People's Hospital
Hangzhou, 310020
China
Status: Recruiting Contact: N/A
Facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 330006
China
Status: Recruiting Contact: N/A
Facility: The First Affliated Hospital Of Nanchang University
Nanchang, 210008
China
Status: Recruiting Contact: N/A
Facility: Nanjing Drum Tower Hospital
Nanjing, 210009
China
Status: Recruiting Contact: N/A
Facility: Jiangsu Cancer Hospital
Nanjing, 200127
China
Status: Recruiting Contact: N/A
Facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
ShangHai, 200400
China
Status: Recruiting Contact: N/A
Facility: Huadong Hospital Affiliated to Fudan University
Shanghai, 110004
China
Status: Recruiting Contact: N/A
Facility: Shengjing Hospital of China Medical University
Shenyang, 110042
China
Status: Recruiting Contact: N/A
Facility: First Affiliated Hospital, Xi'an Jiaotong University
Xi'an, 2100
China
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie de l'Ouest (ICO)
Angers, 25030
France
Status: Recruiting Contact: N/A
Facility: Hopital Jean MINJOZ
Besancon Cedex, 33000
France
Status: Recruiting Contact: N/A
Facility: Institut Bergonié
Bordeaux, 29609
France
Status: Recruiting Contact: N/A
Facility: CHRU Brest - Hôpital Morvan
Brest, 63011
France
Status: Recruiting Contact: N/A
Facility: Centre Jean Perrin
Clermont Ferrand, 21079
France
Status: Recruiting Contact: N/A
Facility: Centre Georges-François Leclerc
Dijon, 38043 Cedex 9
France
Status: Recruiting Contact: N/A
Facility: Centre Oscar Lambret
Lille, 56322
France
Status: Recruiting Contact: N/A
Facility: Groupe Hospitalier Bretagne Sud
Lorient, 69008
France
Status: Recruiting Contact: N/A
Facility: Hopital de la Timone
Marseille, 34298
France
Status: Recruiting Contact: N/A
Facility: Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 06189
France
Status: Recruiting Contact: N/A
Facility: Centre Antoine Lacassagne
Nice, 30029
France
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie du Gard
Nîmes, 75475
France
Status: Recruiting Contact: N/A
Facility: Hopital Europeen Georges-Pompidou
Paris, 69495
France
Status: Recruiting Contact: N/A
Facility: Hospices Civils de Lyon HCL
Pierre-Bénite, 86021
France
Status: Recruiting Contact: N/A
Facility: CHU De Poitiers
Poitiers Cedex, 51100
France
Status: Recruiting Contact: N/A
Facility: Centre Eugene Marquis
Rennes Cedex, 91130
France
Status: Recruiting Contact: N/A
Facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne
Ris Orangis, 44805
France
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 67098
France
Status: Recruiting Contact: N/A
Facility: Institut Claudius Regaud
Toulouse, 59300
France
Status: Recruiting Contact: N/A
Facility: Centre Les Dentellieres
Valenciennes, 94805
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 10967
France
Status: Recruiting Contact: N/A
Facility: Vivantes Klinikum Am Urban
Berlin, 38126
Germany
Status: Recruiting Contact: N/A
Facility: Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie
Braunschweig, 01307
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 40225
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Duesseldorf
Duesseldorf, 47179
Germany
Status: Recruiting Contact: N/A
Facility: Friedrich-Alexander Universitaet Urologische Universitaetskl
Erlangen, 60590
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Frankfurt
Frankfurt, 79106
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsmedizin Göttingen
Göttingen, 22763
Germany
Status: Recruiting Contact: N/A
Facility: Asklepios Klinik Altona
Hamburg, 30625
Germany
Status: Recruiting Contact: N/A
Facility: Medizinische Hochschule Hannover
Hannover, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck, 55131
Germany
Status: Recruiting Contact: N/A
Facility: Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, 48149
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Muenster
Muenster, 72622
Germany
Status: Recruiting Contact: N/A
Facility: Studienpraxis Urologie Drs. Feyerabend
Nuertingen, 93053
Germany
Status: Recruiting Contact: N/A
Facility: Caritas-Krankenhaus St. Josef
Regensburg, 18057
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsmedizin Rostock
Rostock, 72076
Germany
Status: Recruiting Contact: N/A
Facility: MVZ-Onkologie Velbert GbR
Velbert, 92637
Germany
Status: Recruiting Contact: N/A
Facility: Kliniken Nordoberpfalz AG/Klinikum Weiden
Weiden, 26504
Germany
Status: Recruiting Contact: N/A
Facility: Errikos Dunant Hospital Center
Athens, 15125
Greece
Status: Recruiting Contact: N/A
Facility: Athens Medical Center
Athens, 15562
Greece
Status: Recruiting Contact: N/A
Facility: Metropolitan General A.E.
Athens, 115 28
Greece
Status: Recruiting Contact: N/A
Facility: University of Athens Medical School - Regional General Hospi
Athina, 41110
Greece
Status: Recruiting Contact: N/A
Facility: University Hospital Of Larissa
Larisa, 14564
Greece
Status: Recruiting Contact: N/A
Facility: Interbalkan European Medical Center
Thessaloniki, 54645
Greece
Status: Recruiting Contact: N/A
Facility: Euromedica General Clinic
Thessaloniki, 56403
Greece
Status: Recruiting Contact: N/A
Facility: 'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, 1082
Greece
Status: Recruiting Contact: N/A
Facility: Semmelweis Egyetem
Budapest, 1122
Hungary
Status: Recruiting Contact: N/A
Facility: Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály
Budapest, H-1145
Hungary
Status: Recruiting Contact: N/A
Facility: Uzsoki Utcai Korhaz
Budapest, 04400
Hungary
Status: Recruiting Contact: N/A
Facility: Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 8900
Hungary
Status: Recruiting Contact: N/A
Facility: Rambam Health Care Campus
Haifa, 91120
Israel
Status: Recruiting Contact: N/A
Facility: Hadassah Medical Center
Jerusalem, 44281
Israel
Status: Recruiting Contact: N/A
Facility: Meir Medical Center
Kfar Saba, 49100
Israel
Status: Recruiting Contact: N/A
Facility: Rabin Medical Center, Beilinson Hospital
Petach Tikvah, 52621
Israel
Status: Recruiting Contact: N/A
Facility: The Chaim Sheba Medical Center
Tel Hashomer, 64239
Israel
Status: Recruiting Contact: N/A
Facility: Sourasky Medical Center
Tel-Aviv, 70300
Israel
Status: Recruiting Contact: N/A
Facility: Assaf Harofeh Medical Center
Zerifin, 15121
Israel
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria, 52100
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale S. Donato - Asl 8 Arezzo
Arezzo, 33081
Italy
Status: Recruiting Contact: N/A
Facility: CRO, IRCCS, Istituto Nazionale Tumori
Aviano, 24127
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 25123
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 26100
Italy
Status: Recruiting Contact: N/A
Facility: Istituti Ospitalieri di Cremona, AO di Cremona
Cremona, 50139
Italy
Status: Recruiting Contact: N/A
Facility: Oncologia Medica
Firenze, 16132
Italy
Status: Recruiting Contact: N/A
Facility: SPDC Villa Scassi
Genova, 47014
Italy
Status: Recruiting Contact: N/A
Facility: UOC Oncologia Ospedale Provinciale di Macerata
Macerata, 20133
Italy
Status: Recruiting Contact: N/A
Facility: IRST Meldola - Forlì
Meldola, 20141
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20132
Italy
Status: Recruiting Contact: N/A
Facility: European Institute of Oncology
Milano, 41124
Italy
Status: Recruiting Contact: N/A
Facility: AOU Policlinico di Modena
Modena, 28100
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS-Fondazione Pascale
Napoli, 10043
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Maggiore della Carità
Novara, 35128
Italy
Status: Recruiting Contact: N/A
Facility: Aou San Luigi Gonzaga
Orbassano, 43126
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Oncologico Veneto Iov Irccs Padova
Padova, 27100
Italy
Status: Recruiting Contact: N/A
Facility: AOU di Parma
Parma, 27100
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Policlinico San Matteo
Pavia, 56126
Italy
Status: Recruiting Contact: N/A
Facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo
Pavia, 53100
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero Universitaria Pisana
Pisa, 00168
Italy
Status: Recruiting Contact: N/A
Facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
Poggibonsi (SI), 53100
Italy
Status: Recruiting Contact: N/A
Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 10123
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
Siena, 60126
Italy
Status: Recruiting Contact: N/A
Facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino
Torino, 260-8717
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti
Torrette Di Ancona, 036-8563
Italy
Status: Recruiting Contact: N/A
Facility: Chiba Cancer Center
Chiba, 277-8577
Japan
Status: Recruiting Contact: N/A
Facility: Hirosaki University Hospital
Hirosaki, 761-0793
Japan
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital East
Kashiwa, 650-0047
Japan
Status: Recruiting Contact: N/A
Facility: Kagawa University Hospital
Kita-Gun, 343-8555
Japan
Status: Recruiting Contact: N/A
Facility: Kobe City Medical Center General Hospital
Kobe, 791-0280
Japan
Status: Recruiting Contact: N/A
Facility: Dokkyo Medical University Saitama Medical Center
Koshigaya, 889-1692
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organizaiton Shikoku Cancer Center
Matsuyama, 381-8551
Japan
Status: Recruiting Contact: N/A
Facility: University of Miyazaki Hospital
Miyazaki, 464-8681
Japan
Status: Recruiting Contact: N/A
Facility: Nagano Municipal Hospital
Nagano, 589-8511
Japan
Status: Recruiting Contact: N/A
Facility: Aichi Cancer Center Hospital
Nagoya-Shi, 541-8567
Japan
Status: Recruiting Contact: N/A
Facility: Kindai University Hospital
Osaka-Sayama, 545-8586
Japan
Status: Recruiting Contact: N/A
Facility: Osaka International Cancer Institute
Osaka, 373-8550
Japan
Status: Recruiting Contact: N/A
Facility: Osaka City University Hospital
Osaka, 252-0375
Japan
Status: Recruiting Contact: N/A
Facility: Gunma Prefectural Cancer Center
Ota, 285-8741
Japan
Status: Recruiting Contact: N/A
Facility: Kitasato University Hospital
Sagamihara, 003-0804
Japan
Status: Recruiting Contact: N/A
Facility: Toho University Sakura Medical Center
Sakura, 160-8582
Japan
Status: Recruiting Contact: N/A
Facility: National Hospital Organization Hokkaido Cancer Center
Sapporo, 162-8666
Japan
Status: Recruiting Contact: N/A
Facility: Tokyo Women's Medical University Hospital
Shinjuku-ku, 135-8550
Japan
Status: Recruiting Contact: N/A
Facility: Toranomon Hospital
Tokyo, 305-8576
Japan
Status: Recruiting Contact: N/A
Facility: The Cancer Institute Hospital of JFCR
Tokyo, 755-8505
Japan
Status: Recruiting Contact: N/A
Facility: University of Tsukuba Hospital
Tsukuba, 232-0024
Japan
Status: Recruiting Contact: N/A
Facility: Yamaguchi University Hospital
Ube, 49241
Japan
Status: Recruiting Contact: N/A
Facility: Yokohama City University Medical Center
Yokohama, 35015
Japan
Status: Recruiting Contact: N/A
Facility: Pusan National University Hospital
Busan, 410-769
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chungnam National University Hospital
Daejeon, 61469
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyangsi, 21565
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Chonnam National University Hospital
Gwangju, 463-707
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Gachon University Gil Medical Center
Incheon, 02841
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Bundang Hospital
Seongnam, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Korea University Anam Hospital
Seoul, 03181
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Kangbuk Samsung Hospital
Seoul, 135-710
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Severance Hospital, Yonsei University Health System
Seoul, 26426
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 20230
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Yonsei University Wonju Severance Christian Hospital
Wonju-si, 31000
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Medicos Especialistas en Cancer, S.C.
Aguascalientes, 53100
Mexico
Status: Recruiting Contact: N/A
Facility: Oncología Integral Satelite
Naucalpan, 2545 CH
Mexico
Status: Recruiting Contact: N/A
Facility: NKI-AVL, Amsterdam
Amsterdam, 3430 EM
Netherlands
Status: Recruiting Contact: N/A
Facility: Haga ziekenhuis
Den Haag, 6525 GA
Netherlands
Status: Recruiting Contact: N/A
Facility: St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 15-027
Netherlands
Status: Recruiting Contact: N/A
Facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 02-781
Poland
Status: Recruiting Contact: N/A
Facility: Centralny Szpital Kliniczny MSWiA w Warszawie
Warszawa, 50-556
Poland
Status: Recruiting Contact: N/A
Facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa, 1500-458
Poland
Status: Recruiting Contact: N/A
Facility: Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, 1649-035
Poland
Status: Recruiting Contact: N/A
Facility: Hospital Lusíadas
Lisboa, G1R 2J6
Portugal
Status: Recruiting Contact: N/A
Facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte
Lisboa, 1400-038
Portugal
Status: Recruiting Contact: N/A
Facility: Hospital Santo Antonio dos Capuchos
Lisboa, 4200072
Portugal
Status: Recruiting Contact: N/A
Facility: Champalimaud Foundation Champalimaud Centre
Lisbon, 656049
Portugal
Status: Recruiting Contact: N/A
Facility: Instituto Portugues de Oncologia
Porto, 454087
Portugal
Status: Recruiting Contact: N/A
Facility: Altai Regional Oncology Dispensary
Barnaul, 664035
Russian Federation
Status: Recruiting Contact: N/A
Facility: Irkutsk Regional Oncology Dispensary
Irkutsk, 236029
Russian Federation
Status: Recruiting Contact: N/A
Facility: Ivanovo Regional Oncology Dispensary
Ivanovo, 156005
Russian Federation
Status: Recruiting Contact: N/A
Facility: Kostroma regional oncology dispensary
Kostroma, 105077
Russian Federation
Status: Recruiting Contact: N/A
Facility: Leningrad Regional Oncology Dispensary
Kuzmolovsky, 115478
Russian Federation
Status: Recruiting Contact: N/A
Facility: City Clinical Hospital n.a. D.D.Pletnev
Moscow, 117997
Russian Federation
Status: Recruiting Contact: N/A
Facility: FSBSI 'N. N. Blokhin Russian Cancer Research Center'
Moscow, 119991
Russian Federation
Status: Recruiting Contact: N/A
Facility: I.M. Sechenov First Moscow State Medical University
Moscow, 360017
Russian Federation
Status: Recruiting Contact: N/A
Facility: Hertzen Oncology Research Institute
Moscow, 603109
Russian Federation
Status: Recruiting Contact: N/A
Facility: City Clinical Hospital #1
Nalchik, 249036
Russian Federation
Status: Recruiting Contact: N/A
Facility: Privolzhsky District Medical Center under the Federal Medico-Biological Agency
Nizhni Novgorod, 644013
Russian Federation
Status: Recruiting Contact: N/A
Facility: Clinical Oncology Dispensary
Omsk, 194354
Russian Federation
Status: Recruiting Contact: N/A
Facility: Private Medical Institution Euromedservice
Saint Petersburg, 192148
Russian Federation
Status: Recruiting Contact: N/A
Facility: LLC 'Strategic Medical Systems'
Saint-Petersburg, 430032
Russian Federation
Status: Recruiting Contact: N/A
Facility: Clinical hopital n/a Petra velikogo
Saint-Petersburg, 410000
Russian Federation
Status: Recruiting Contact: N/A
Facility: LLC Uromed
Smolensk, 197758
Russian Federation
Status: Recruiting Contact: N/A
Facility: GBUZ Oncology Centre #2 of Healthcare Department of Krasno
Sochi, 197758
Russian Federation
Status: Recruiting Contact: N/A
Facility: Multifunctional clinical medical center 'Medical city'
Tyumen, 160012
Russian Federation
Status: Recruiting Contact: N/A
Facility: Bashkiria State Medical University
Ufa, 06006
Russian Federation
Status: Recruiting Contact: N/A
Facility: Vologda Regional Oncological Dispensary
Vologda, 08916
Russian Federation
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Infanta Cristina
Badajoz, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol
Badalona, 08041
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Clinic I Provincial de Barcelona
Barcelona, 10003
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. de La Santa Creu I Sant Pau
Barcelona, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Reina Sofia
Córdoba, 23007
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Virgen de Las Nieves
Granada, 35016
Spain
Status: Recruiting Contact: N/A
Facility: Complejo Hospitalario de Jaen
Jaén, 27003
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Lucus Augusti
Lugo, 28033
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. La Paz
Madrid, 28220
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. 12 de Octubre
Madrid, 08243
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 29010
Spain
Status: Recruiting Contact: N/A
Facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa
Manresa, 31008
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. de Navarra
Pamplona, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen Macarena
Sevilla, 46014
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen Del Rocio
Sevilla, 46026
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. I Politecni La Fe
Valencia, 807
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Miguel Servet
Zaragoza, 833
Spain
Status: Recruiting Contact: N/A
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 40447
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang Gung Medical Foundation
Niao-Sung Hsiang, 40705
Taiwan
Status: Recruiting Contact: N/A
Facility: Taichung Veterans General Hospital
Taichung, 710
Taiwan
Status: Recruiting Contact: N/A
Facility: National Cheng Kung University Hospital
Tainan, 10002
Taiwan
Status: Recruiting Contact: N/A
Facility: Chi Mei Medical Center - Yong Kang
Tainan, 10449
Taiwan
Status: Recruiting Contact: N/A
Facility: National Taiwan University Hospital
Taipei City, 11217
Taiwan
Status: Recruiting Contact: N/A
Facility: Mackay Memorial Hospital
Taipei, 11259
Taiwan
Status: Recruiting Contact: N/A
Facility: Taipei Veterans General Hospital
Taipei, 333
Taiwan
Status: Recruiting Contact: N/A
Facility: Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 01120
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 6100
Taiwan
Status: Recruiting Contact: N/A
Facility: Baskent University Adana Practice and Research Center Kisla Health Campus
Adana, 34093
Turkey
Status: Recruiting Contact: N/A
Facility: Hacettepe University Medical Faculty
Ankara, 34098
Turkey
Status: Recruiting Contact: N/A
Facility: Bezmialem University Medical Faculty
Istanbul, 34147
Turkey
Status: Recruiting Contact: N/A
Facility: Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34214
Turkey
Status: Recruiting Contact: N/A
Facility: Bakirkoy Training and Research Hospital
Istanbul, 34722
Turkey
Status: Recruiting Contact: N/A
Facility: Medipol Mega University Hospital
Istanbul, 34890
Turkey
Status: Recruiting Contact: N/A
Facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
Istanbul, 35100
Turkey
Status: Recruiting Contact: N/A
Facility: Pendik Training and Research Hospital
Istanbul, 35340
Turkey
Status: Recruiting Contact: N/A
Facility: Ege University
Izmir, 35360
Turkey
Status: Recruiting Contact: N/A
Facility: Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 44400
Turkey
Status: Recruiting Contact: N/A
Facility: Kocaeli University Medical Faculty
Kocaeli, 49005
Turkey
Status: Recruiting Contact: N/A
Facility: MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov
Dnipropetrovsk, 76008
Ukraine
Status: Recruiting Contact: N/A
Facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
Dnipro, 61037
Ukraine
Status: Recruiting Contact: N/A
Facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, 61070
Ukraine
Status: Recruiting Contact: N/A
Facility: Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 03022
Ukraine
Status: Recruiting Contact: N/A
Facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 03115
Ukraine
Status: Recruiting Contact: N/A
Facility: Municipal non-profit enterprise 'Regional Center of Oncology'
Kharkiv, 79010
Ukraine
Status: Recruiting Contact: N/A
Facility: National Cancer Institute
Kyiv, 88000
Ukraine
Status: Recruiting Contact: N/A
Facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 21029
Ukraine
Status: Recruiting Contact: N/A
Facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 69040
Ukraine
Status: Recruiting Contact: N/A
Facility: Transkarpathian Regional University Oncology Clinic
Uzhgorod, 69600
Ukraine
Status: Recruiting Contact: N/A
Facility: Podilskiy Regional Center of Oncology
Vinnitsa, BS2 8ED
Ukraine
Status: Recruiting Contact: N/A
Facility: University Hospitals Bristol - Bristol Haematology & Oncolog
Bristol, W6 8RF
United Kingdom
Status: Recruiting Contact: N/A
Facility: St Bartholomew's Hospital
London, M20 4BX
United Kingdom
Status: Recruiting Contact: N/A
Facility: Sarah Cannon Research Institute
London, PL6 8QH
United Kingdom
Status: Recruiting Contact: N/A
Facility: Charing Cross Hospital
London, S10 2 RX
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Christie NHS Foundation Trust - Christie Hospital
Manchester, SO16 6YD
United Kingdom
Status: Recruiting Contact: N/A
Facility: Derriford Hospital-Department of Medical Oncology
Plymouth, SM2 5NG
United Kingdom
Status: Recruiting Contact: N/A
Facility: University of Sheffield
Sheffield,
United Kingdom
Status: Recruiting Contact: N/A
Facility: Southampton General Hospital
Southampton,
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Marsden Hospital
Sutton,
United Kingdom
Status: Recruiting Contact: N/A