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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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390504
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

Condition or disease Intervention/treatment Phase
Urothelial Cancer Drug: Erdafitinib Drug: Vinflunine Drug: Docetaxel Drug: Pembrolizumab Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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 followup (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : November 24, 2020
Estimated Study Completion Date : November 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 (Arm 1A): Erdafitinib
Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).
Drug: Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Other Name: JNJ-42756493

Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.

Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.
Drug: Vinflunine
Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.

Drug: Docetaxel
Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.

Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.

Experimental: Cohort 2 (Arm 2A): Erdafitinib
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).
Drug: Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Other Name: JNJ-42756493

Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.

Experimental: Cohort 2 (Arm 2B): Pembrolizumab
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.
Drug: Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Date of first randomization to the date of participant's death (approximately up to 3 years) ]
    Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years) ]
    PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.

  2. Overall Response Rate (ORR) [ Time Frame: Approximately up to 3 years ]
    ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.

  3. Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) [ Time Frame: Baseline up to end of treatment (approximately 3 years) ]
    The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.

  4. Change from Baseline in Patient-Global Impression of Severity (PGIS) Score [ Time Frame: Baseline up to end of treatment (approximately 3 years) ]
    The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.

  5. Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L [ Time Frame: Baseline up to follow up phase (approximately 3 years) ]
    European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.

  6. Change from Baseline in the Utility Scale of the EQ-5D-5L [ Time Frame: Baseline up to follow up phase (approximately 3 years) ]
    The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.

  7. Duration of Response (DOR) [ Time Frame: From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years) ]
    DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.

  8. Number of Participants with Adverse Events (AEs) as a Measure of Safety [ Time Frame: Approximately up to 3 years ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  9. Oral Clearance (CL/F) of Erdafitinib [ Time Frame: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ]
    CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.

  10. Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib [ Time Frame: Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days) ]
    AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.



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:

  • 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

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): NCT03390504


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Locations
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United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center Recruiting
Anchorage, Alaska, United States, 99503
United States, Arizona
University Of UA Cancer Center(UACC)/DH-SJHMC Withdrawn
Phoenix, Arizona, United States, 85004
United States, California
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center Withdrawn
Orange, California, United States, 92868
University of Calif Davis Medical Center Recruiting
Sacramento, California, United States, 95817
St. Helena Hospital - Martin-O'Neil Cancer Center Recruiting
Saint Helena, California, United States, 94574
Kaiser Permanente Medical Center Not yet recruiting
Vallejo, California, United States, 95119
United States, Colorado
UCHealth Anschutz Cancer Pavilion Withdrawn
Aurora, Colorado, United States, 80045
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami/Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Mid-Florida Hematology Oncology Recruiting
Orange, Florida, United States, 32763
United States, Georgia
Piedmont Cancer Institute Recruiting
Atlanta, Georgia, United States, 30318-0922
United States, Idaho
St. Luke's Meridian Medical Center Withdrawn
Meridian, Idaho, United States, 83642
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Edward Hines Jr V A Hospital Not yet recruiting
Hines, Illinois, United States, 60141
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109-5000
United States, Nebraska
University of Nebraska Medical Center Withdrawn
Omaha, Nebraska, United States, 68198-0600
United States, Nevada
VA Sierra Nevada Health Care System Recruiting
Reno, Nevada, United States, 89509
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Weill Cornell Medical College Recruiting
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center Withdrawn
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute, Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Withdrawn
Durham, North Carolina, United States, 27701
W. G. 'Bill' Hefner VA Medical Center Recruiting
Salisbury, North Carolina, United States, 28144
United States, Pennsylvania
Penn State Hershey Cancer Institute Withdrawn
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh Medical Center (UPMC) Withdrawn
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
University of Missouri Withdrawn
Columbia, South Carolina, United States, 65212-1000
United States, Texas
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
INOVA Dwiight &Martha Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
VA Puget Sound Healthcare System Recruiting
Seattle, Washington, United States, 98108
Australia
Chris O'Brien Lifehouse Recruiting
Camperdown, Australia, 2050
Peninsula & South Eastern Haematology and Oncology Group Recruiting
Frankston, Australia, 3199
Royal Hobart Hospital Withdrawn
Hobart, Australia, 7000
St. George Private Hospital, Oncology Day Care Centre Recruiting
Kogarah, Australia, 2217
Peter MacCallum Cancer Centre Recruiting
Melbourne, Australia, 3000
Frankston Hospital Recruiting
Melbourne, Australia, 3199
Fiona Stanley Hospital Recruiting
Murdoch, Australia, 6150
Austria
LKH-Univ. Klinikum Graz Recruiting
Graz, Austria, 8036
Ordensklinikum Linz GmbH Elisabethinen Recruiting
Linz, Austria, 4020
LKH - Universitätsklinikum der PMU Salzburg Recruiting
Salzburg, Austria, 5020
Medical University Vienna, MUV Recruiting
Vienna, Austria, A-1090
Belgium
OLV Ziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Cliniques Universitaires Saint-Luc Recruiting
Brussel, Belgium, 1200
Clinique Notre Dame de Grâce Recruiting
Charleroi, Belgium, 6000
AZ Maria Middelares Recruiting
Gent, Belgium, 9000
UZ Gent Recruiting
Gent, Belgium, 9000
CHC-Cliniques Saint-Joseph Recruiting
Liège, Belgium, 4000
Sint-Augustinus AZ Recruiting
Wilrijk, Belgium, 2610
Chu Dinant Godinne UCL Namur Recruiting
Yvoir, Belgium, 5530
Brazil
Fundacao Pio Xii - Hospital De Cancer De Barretos Recruiting
Barretos, Brazil, 14784-400
Associação Mário Penna\Núcleo de Ensino e Pesquisas Recruiting
Belo Horizonte, Brazil, 30380-472
Hospital Erasto Gaertner Recruiting
Curitiba, Brazil, 81520-060
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Not yet recruiting
Goiânia, Brazil, 74605-070
Clínica de Neoplasias Litoral Ltda. Recruiting
Itajai, Brazil, 88301-220
Upco - Hcpa Recruiting
Porto Alegre, Brazil, 90035-903
INCA - Instituto Nacional Do Cancer Recruiting
Rio de Janeiro, Brazil, 20231-050
Oncoclínicas Not yet recruiting
Rio de Janeiro, Brazil, 22250-905
Fundacao Antonio Prudente Recruiting
Sao Paulo, Brazil, 01509900
Ibcc - Instituto Brasileiro de Controle Do Cancer Not yet recruiting
Sao Paulo, Brazil
Hospital de Base de São José do Rio Preto Recruiting
São José do Rio Preto, Brazil, 15090-000
Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes Recruiting
São Paulo, Brazil, 01308901
Instituto D'Or de Pesquisa e Ensino (IDOR) Not yet recruiting
São Paulo, Brazil, 04502-001
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil, 05651-900
CEPHO - Faculdade de Medicina do ABC Recruiting
São Paulo, Brazil, 09060-650
Canada, British Columbia
BC Cancer Agency - Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Cancercare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Princess Margaret Hospital- UHN Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Saskatchewan
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre Not yet recruiting
Regina, Saskatchewan, Canada, S4T 7T1
China
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, China, 100021
Peking University First Hospital Recruiting
Beijing, China, 100034
Beijing Friendship Hospital Recruiting
Beijing, China, 100050
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
Beijing Hospital Recruiting
BeiJing, China, 100730
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 100730
Sichuan Provincial People's Hospital Recruiting
Chengdu, China, 610000
Chongqing Medical University Not yet recruiting
Chongqing, China, 400030
Sun Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, China, 510060
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, China, 510120
Guangzhou First Municipal People's Hospital Recruiting
Guangzhou, China, 510180
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, China, 310014
Sir Run Run Shaw Hospital, Zhejiang University Recruiting
Hangzhou, China, 310020
The First Affliated Hospital Of Nanchang University Recruiting
Nanchang, China, 330006
Nanjing Drum Tower Hospital Recruiting
Nanjing, China, 210008
Jiangsu Cancer Hospital Recruiting
Nanjing, China, 210009
Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
ShangHai, China, 200127
Huadong Hospital Affiliated to Fudan University Recruiting
Shanghai, China, 200400
Shengjing Hospital of China Medical University Not yet recruiting
Shenyang, China, 110004
First Affiliated Hospital, Xi'an Jiaotong University Recruiting
Xi'an, China, 710061
France
Institut de Cancérologie de l'Ouest (ICO) Recruiting
Angers, France, 49055
Hopital Jean MINJOZ Recruiting
Besancon Cedex, France, 25030
Institut Bergonié Recruiting
Bordeaux, France, 33000
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Centre Georges-François Leclerc Not yet recruiting
Dijon, France, 21079
Centre Oscar Lambret Recruiting
Lille, France, 59020
Centre Leon Bérard Not yet recruiting
Lyon, France, 69008
Hopital de la Timone Not yet recruiting
Marseille, France, 13005
Institut Regional du Cancer de Montpellier Val d'Aurelle Recruiting
Montpellier, France, 34298
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Institut de Cancérologie du Gard Recruiting
Nîmes, France, 30029
Hospital Saint-Louis Terminated
Paris Cedex 10, France, 75475
Hopital Europeen Georges-Pompidou Recruiting
Paris, France, 75015
Hospices Civils de Lyon HCL Recruiting
Pierre-Bénite, France, 69495
CHU De Poitiers Recruiting
Poitiers Cedex, France, 86021
Centre Hopitalier Inter-Communal De Cornouaille Recruiting
Quimper, France, 29000
Centre Eugene Marquis Recruiting
Rennes Cedex, France, 35062
I.C.O. René Gauducheau Not yet recruiting
Saint Herblain Cedex, France, 44805
Institut de Cancérologie de Loire Recruiting
Saint-Priest-en-Jarez, France, 42271
Hopitaux universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Centre Les Dentellieres Recruiting
Valenciennes, France, 59300
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie Not yet recruiting
Braunschweig, Germany, 38126
Universitatsklinikum Carl Gustav Carcus Dresden Not yet recruiting
Dresden, Germany, 01307
Universitaetsklinikum Duesseldorf Not yet recruiting
Duesseldorf, Germany, 40225
Friedrich-Alexander Universitaet Urologische Universitaetskl Not yet recruiting
Erlangen, Germany, 91054
Universitatsklinikum Frankfurt Not yet recruiting
Frankfurt, Germany, 60590
Universitatsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
Universitätsmedizin Greifswald Not yet recruiting
Greifswald, Germany, 17475
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany, 37099
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes Withdrawn
Homburg/Saar, Germany, 66421
Universitätsklinikum Schleswig Holstein Campus Lübeck Not yet recruiting
Lubeck, Germany, 23538
Medizinische Fakultät Mannheim der Universität Heidelberg Not yet recruiting
Mannheim, Germany, 68167
Universitaetsklinikum Muenster Not yet recruiting
Muenster, Germany, 48149
Studienpraxis Urologie Drs. Feyerabend Recruiting
Nuertingen, Germany, 72622
Caritas-Krankenhaus St. Josef Not yet recruiting
Regensburg, Germany, 93053
Universitaetsmedizin Rostock Not yet recruiting
Rostock, Germany, 18057
MVZ-Onkologie Velbert GbR Not yet recruiting
Velbert, Germany, 42551
Kliniken Nordoberpfalz AG/Klinikum Weiden Not yet recruiting
Weiden, Germany, 92637
Greece
University General Hospital of Rio Patras Recruiting
Achaïa, Greece, 26504
Errikos Dunant Hospital Center Recruiting
Athens, Greece, 11526
Athens Medical Center Recruiting
Athens, Greece, 15125
Metropolitan General A.E. Recruiting
Athens, Greece, 15562
University of Athens Medical School - Regional General Hospi Recruiting
Athina, Greece, 115 28
University Hospital Of Larissa Recruiting
Larisa, Greece, 41110
Interbalkan European Medical Center Recruiting
Thessaloniki, Greece, 14564
Euromedica General Clinic Recruiting
Thessaloniki, Greece, 54645
'Papageorgiou' General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 56403
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1082
Orszagos Onkologiai Intezet Recruiting
Budapest, Hungary, 1122
Uzsoki Utcai Korhaz Recruiting
Budapest, Hungary, H-1145
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Recruiting
Nyíregyháza, Hungary, 04400
Pécsi Tudományegyetem Klinikai Központ Recruiting
Pécs, Hungary, 7624
India
Manipal Comprehensive Cancer Centre, Manipal Hospital Suspended
Bangalore, India, 560 017
Apollo Specialty Hospital Suspended
Chennai, India, 600035
Bhagwan Mahaveer Hospital & Research Centre Suspended
Jaipur, India, 302017
Sahyadri Speciality Hospital Suspended
Pune, India, 411001
Deenanath Mangeshkar Hospital and Research Centre Suspended
Pune, India, 411004
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center, Beilinson Hospital Recruiting
Petach Tikvah, Israel, 49100
The Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria Not yet recruiting
Alessandria, Italy, 15121
Ospedale S. Donato - Asl 8 Arezzo Recruiting
Arezzo, Italy, 52100
CRO, IRCCS, Istituto Nazionale Tumori Recruiting
Aviano, Italy, 33081
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili Recruiting
Brescia, Italy, 25123
Istituti Ospitalieri di Cremona, AO di Cremona Recruiting
Cremona, Italy, 26100
Oncologia Medica Not yet recruiting
Firenze, Italy, 50139
Policlinico Hospital San Martino- IRCCS for Oncology Withdrawn
Genova, Italy, 16132
UOC Oncologia Ospedale Provinciale di Macerata Not yet recruiting
Macerata, Italy, 62100
IRST Meldola - Forlì Recruiting
Meldola, Italy, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
European Institute of Oncology Recruiting
Milano, Italy, 20141
AOU Policlinico di Modena Not yet recruiting
Modena, Italy, 41124
IRCCS-Fondazione Pascale Recruiting
Napoli, Italy, 80131
Ospedale Maggiore della Carità Recruiting
Novara, Italy, 28100
Aou San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Istituto Oncologico Veneto Iov Irccs Padova Recruiting
Padova, Italy, 35128
AOU di Parma Not yet recruiting
Parma, Italy, 43126
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo Recruiting
Pavia, Italy, 27100
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST Recruiting
Poggibonsi (SI), Italy, 53100
Fondazione Policlinico Universitario A. Gemelli IRCCS Not yet recruiting
Roma, Italy, 00168
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte Not yet recruiting
Siena, Italy, 53100
Oncologia Medica-Città Della Salute E Della Scienza Di Torino Recruiting
Torino, Italy, 10123
Azienda Ospedaliero - Universitaria Ospedali Riuniti Recruiting
Torrette Di Ancona, Italy, 60126
Japan
Chiba Cancer Center Recruiting
Chiba, Japan, 260-8717
Hirosaki University School of Medicine & Hospital Recruiting
Hirosaki, Japan, 036-8563
National Cancer Center Hospital East Recruiting
Kashiwa, Japan, 277-8577
Kagawa University Hospital Recruiting
Kita-Gun, Japan, 761-0793
Kobe City Medical Center General Hospital Recruiting
Kobe, Japan, 650-0047
Dokkyo Medical University Saitama Medical Center Recruiting
Koshigaya, Japan, 343-8555
National Shikoku Cancer Center Recruiting
Matsuyama, Japan, 791-0280
University of Miyazaki Hospital Recruiting
Miyazaki, Japan, 889-1692
Nagano Municipal Hospital Recruiting
Nagano, Japan, 381-8551
Aichi Cancer Center Hospital Recruiting
Nagoya-shi, Japan, 464-8681
Kinki University Hospital Recruiting
Osaka-Sayama, Japan, 589-8511
Osaka International Cancer Institute Recruiting
Osaka-shi, Japan, 541-8567
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Kitasato University Hospital Recruiting
Sagamihara, Japan, 252-0375
Toho University Sakura Medical Center Recruiting
Sakura, Japan, 285-8741
National Hospital, Hokkaido Cancer Center Recruiting
Sapporo, Japan, 003-0804
Tokyo Women's Medical University Hospital Recruiting
Shinjuku-ku, Japan, 162-8666
University of Tsukuba Hospital Recruiting
Tsukuba, Japan, 305-8576
Yamaguchi University Hospital Recruiting
Ube, Japan, 755-8505
Yokohama City University Medical Center Recruiting
Yokohama, Japan, 232-0024
Korea, Republic of
Pusan National University Hospital. Recruiting
Busan, Korea, Republic of, 49241
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
National Cancer Center Recruiting
Goyangsi, Korea, Republic of, 410-769
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Yonsei University Wonju Severance Christian Hospital Recruiting
Wonju-si, Korea, Republic of, 26426
Mexico
San Peregrino Cancer Center Recruiting
Aguascalientes, Mexico, 20230
Centro Estatal de Cancerología de Chihuahua Recruiting
Chihuahua, Mexico, 31000
Netherlands
St. Antonius Ziekenhuis Nieuwegein Recruiting
Nieuwegein, Netherlands, 3430 EM
Radboud Umcn Withdrawn
Nijmegen, Netherlands, 6525 GA
Portugal
Hospital Lusíadas Not yet recruiting
Lisboa, Portugal, 1500-458
H. Santa Maria - Centro Hospitalar de Lisboa Norte Not yet recruiting
Lisboa, Portugal, 1649-035
Hospital Santo Antonio dos Capuchos Not yet recruiting
Lisboa, Portugal, G1R 2J6
Champalimaud Foundation Champalimaud Centre Not yet recruiting
Lisbon, Portugal, 1400-038
Instituto Portugues de Oncologia Not yet recruiting
Porto, Portugal, 4200072
Russian Federation
Altai Regional Oncology Dispensary Recruiting
Barnaul, Russian Federation, 656049
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine Recruiting
Chelyabinsk, Russian Federation, 454087
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
Naval Clinical Hospital Not yet recruiting
Kaliningrad, Russian Federation, 236029
City Clinical Hospital n.a. D.D.Pletnev Not yet recruiting
Moscow, Russian Federation, 105077
FSBSI 'N. N. Blokhin Russian Cancer Research Center' Not yet recruiting
Moscow, Russian Federation, 115478
Russian Scientific Center of Roentgenoradiology Recruiting
Moscow, Russian Federation, 117997
Hertzen Oncology Research Institute Recruiting
Moscow, Russian Federation, 125284
Privolzhsky District Medical Center under the Federal Medico-Biological Agency Recruiting
Nizhni Novgorod, Russian Federation, 603109
National Medical Radiological Research Center Withdrawn
Obninsk, Russian Federation, 249036
Clinical Oncology Dispensary Recruiting
Omsk, Russian Federation, 644013
GBUZ of Stavropol region Pyatigorsk Oncological Dispensary Recruiting
Pyatigorsk, Russian Federation, 357502
City Polyprofiled Hospital #2 Withdrawn
Saint Petersburg, Russian Federation, 194354
Private Medical Institution Euromedservice Not yet recruiting
Saint Petersburg, Russian Federation, 196603
Pavlov First Saint Petersburg State Medical University Completed
Saint Petersburg, Russian Federation, 197022
LLC 'Strategic Medical Systems' Recruiting
Saint-Petersburg, Russian Federation, 192148
Clinical hopital n/a Petra velikogo Recruiting
Saint-Petersburg, Russian Federation, 195067
FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva Recruiting
Saransk, Russian Federation, 430032
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410000
GBUZ Oncology Centre #2 of Healthcare Department of Krasno Not yet recruiting
Sochi, Russian Federation, 354057
Russian Scientific Center of Radiology and Surgical Technologies Recruiting
St. Petersburg, Russian Federation, 197758
Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care Completed
St.Petersburg, Russian Federation, 197758
Multifunctional clinical medical center 'Medical city' Recruiting
Tyumen, Russian Federation, 625041
Bashkiria State Medical University Not yet recruiting
Ufa, Russian Federation, 450000
Vologda Regional Oncological Dispensary Not yet recruiting
Vologda, Russian Federation, 160012
Spain
Hosp. Univ. Infanta Cristina Recruiting
Badajoz, Spain, 06006
Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hosp. de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08041
Hosp. Reina Sofia Recruiting
Córdoba, Spain, 14004
Hosp. Univ. Virgen de Las Nieves Recruiting
Granada, Spain, 18014
Complejo Hospitalario de Jaen Recruiting
Jaén, Spain, 23007
Hosp. Univ. Lucus Augusti Recruiting
Lugo, Spain, 27003
Hosp. Gral. Univ. Gregorio Maranon Not yet recruiting
Madrid, Spain, 28009
Centro Oncologico Md Anderson Withdrawn
Madrid, Spain, 28033
Hosp. Univ. La Paz Recruiting
Madrid, Spain, 28046
Hosp. Univ. Pta. de Hierro Majadahonda Recruiting
Majadahonda, Spain, 28220
ALTHAIA, Xarxa Assistencial Universitària de Manresa Recruiting
Manresa, Spain, 08243
Hosp. Virgen de La Victoria Withdrawn
Málaga, Spain, 29010
Hosp. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hosp. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Hosp. Univ. I Politecni La Fe Recruiting
Valencia, Spain, 46026
Hosp. Univ. Miguel Servet Recruiting
Zaragoza, Spain, 50009
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Chi Mei Medical Center - Liu Ying Recruiting
Liou Ying Township, Taiwan, 736
Chang Gung Medical Foundation Recruiting
Niao-Sung Hsiang, Taiwan, 833
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan, 11259
Chang-Gung Memorial Hospital, LinKou Branch Recruiting
Taoyuan, Taiwan, 333
Turkey
Baskent University Adana Practice and Research Center Kisla Health Campus Recruiting
Adana, Turkey, 01120
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 6100
Bezmialem University Medical Faculty Recruiting
Istanbul, Turkey, 34093
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Bakirkoy Training and Research Hospital Recruiting
Istanbul, Turkey, 34147
Medipol Mega University Hospital Recruiting
Istanbul, Turkey, 34214
Marmara University Medical Faculty Recruiting
Istanbul, Turkey, 34890
Istanbul Medeniyet University Goztepe Training and Research Hospital Recruiting
Istanbul, Turkey, 81450
Ege University Recruiting
Izmir, Turkey, 35100
Dokuz Eylul Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 35340
Kocaeli University Medical Faculty Recruiting
Kocaeli, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari Recruiting
Malatya, Turkey, 44400
Ukraine
Chernivtsi Regional Clinical Hospital Withdrawn
Chernivtsi, Ukraine, 58002
MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov Recruiting
Dnipropetrovsk, Ukraine, 49005
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4 Recruiting
Dnipropetrovsk, Ukraine, 49102
Oblasnyi Klinichnyi Onkologichnyi Dyspanser Recruiting
Dnipro, Ukraine, 49100
Oblasna klinichna likarnia - urolohichne viddilennia Recruiting
Ivano-Frankivsk, Ukraine, 76018
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval Not yet recruiting
Kharkiv, Ukraine, 61037
Regional center of oncology Recruiting
Kharkov, Ukraine, 61070
National Cancer Institute Recruiting
Kyiv, Ukraine, 03022
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center Not yet recruiting
Kyiv, Ukraine, 03115
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' Not yet recruiting
Lviv, Ukraine, 79010
Transkarpathian Regional University Oncology Clinic Recruiting
Uzhgorod, Ukraine, 88000
Podilskyi Rehionalnyi Tsentr Onkolohii, Viddilennia Khimioterapii Recruiting
Vinnytsia, Ukraine, 21029
Zaokod Completed
Zaporizhzhia, Ukraine, 69040
Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital Completed
Zaporizhzhia, Ukraine, 69600
United Kingdom
University Hospitals Bristol - Bristol Haematology & Oncolog Recruiting
Bristol, United Kingdom, BS2 8ED
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
The Christie NHS Foundation Trust - Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Derriford Hospital-Department of Medical Oncology Recruiting
Plymouth, United Kingdom, PL6 8QH
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5NG
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03390504     History of Changes
Other Study ID Numbers: CR108401
2017-002932-18 ( EudraCT Number )
42756493BLC3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 19, 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Docetaxel
Pembrolizumab
Vinblastine
Mitogens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic