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A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04083976
Collaborator
(none)
336
Enrollment
208
Locations
1
Arm
108.5
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participants has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is defined as 4 years from enrollment of last participant into study or last follow-up visit of last participant, whichever occurs first. Currently this study is recruiting pediatric participants only.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
336 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
Actual Study Start Date :
Nov 20, 2019
Anticipated Primary Completion Date :
Jun 14, 2022
Anticipated Study Completion Date :
Dec 4, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Erdafitinib

Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of erdafitinib oral tablets until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment.

Drug: Erdafitinib
Participants will receive erdafitinib oral tablets.
Other Names:
  • JNJ-42756493

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC) [Up to 6 years and 9 months]

      ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).

    Secondary Outcome Measures

    1. Overall Response Rate as Assessed by Investigator [Up to 6 years and 9 months]

      ORR as assessed by investigator is defined as the percentage of participants who achieve a CR or PR.

    2. Duration of Response (DOR) [Up to 6 years and 9 months]

      DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.

    3. Disease Control Rate (DCR) [Up to 6 years and 9 months]

      DCR is defined as the percentage of participants with CR, PR or stable disease (SD).

    4. Clinical Benefit Rate (CBR) [Up to 6 years and 9 months]

      CBR is defined as the percentage of participants with CR, PR or durable SD.

    5. Progression Free Survival (PFS) [Up to 6 years and 9 months]

      PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.

    6. Overall Survival (OS) [Up to 6 years and 9 months]

      OS will be measured from the date of first dose of study drug to the date of the participant's death.

    7. Plasma Concentrations of Erdafitinib [Predose and 2-4 hours postdose]

      Plasma concentrations of erdafitinib will be reported.

    8. Number of Participants with Adverse Events (AEs) [Up to 6 years and 9 months]

      An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the relevant investigational product.

    9. Number of Participants with Adverse Events by Severity [Up to 6 years and 9 months]

      An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Adverse event severity is a clinical determination of the intensity of an adverse event.

    10. Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score [Baseline; up to 6 years and 9 months]

      The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    11. Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score [Baseline; up to 6 years and 9 months]

      The PGIS is a single question regarding the patient report of disease severity: considering all aspects of your cancer symptoms right now would you say your cancer symptoms are none, mild, moderate, severe, or very severe?

    12. Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale [Baseline; up to 6 years and 9 months]

      The PGIC is the patient-reported outcome (PRO) counterpart to the clinical global impressions (CGI) scale. The PGIC is a single verbal rating scale ranging from 1 = a lot better now to 7 = a lot worse now.

    13. Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score [Baseline; up to 6 years and 9 months]

      The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    14. Change from Baseline in Pediatric Functional Assessment of Cancer Therapy - Brain (Peds FACT-Br) Total Score [Baseline; up to 6 years and 9 months]

      Peds FACT-Br consists of 4 sets of disease-specific questions pertaining to brain neoplasms (a set of 34 to 37 questions each for child, parent of child, adolescent or parent of adolescent). Peds FACT-Br total score for child ranges from 0-136 and for parent of child, adolescent and parent of adolescent the score ranges from 0-148. Here '0' indicates a severely "symptomatic participant" and highest score indicates "asymptomatic participant".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion

    • Measurable disease

    • Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies

    • Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

    Exclusion Criteria:

    • Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib

    • The presence of FGFR gatekeeper and resistance mutations

    • Histologic demonstration of urothelial carcinoma

    • Hematologic malignancy (i.e., myeloid and lymphoid neoplasms

    • For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS

    • Active malignancies other than for disease requiring therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates, PC - HOPE Tucson Arizona United States 85711
    2 Highlands Oncology Group Fayetteville Arkansas United States 72703
    3 Rocky Mountain Cancer Centers Colorado Springs Colorado United States 80907
    4 Yale University New Haven Connecticut United States 06520
    5 Eastern Connecticut Hematology & Oncology Assoc. Norwich Connecticut United States 06360
    6 Medical Oncology Hematology Consultants, PA Newark Delaware United States 19713
    7 Memorial Cancer Institute Hollywood Florida United States 33021
    8 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    9 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    10 Emory University Atlanta Georgia United States 30022
    11 Hawaii Cancer Care 'Aiea Hawaii United States 96701
    12 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    13 Maine Medical Center Scarborough Maine United States 04074
    14 Frederick Health Hospital - James M Stockman Cancer Institute Frederick Maryland United States 21702
    15 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    16 Henry Ford Hospital Detroit Michigan United States 48202
    17 Hackensack University Medical Center Hackensack New Jersey United States 07601
    18 Mount Sinai New York New York United States 10029
    19 Memorial Sloan Kettering Cancer Center New York New York United States 10128
    20 Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina United States 28204
    21 Oncology Hematology Care Cincinnati Ohio United States 45242
    22 Nationwide Children's Hospital Columbus Ohio United States 43205
    23 Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma United States 74146
    24 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    25 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    26 Tennessee Oncology, PLLC Chattanooga Tennessee United States 37404
    27 Tennessee Oncology Nashville Tennessee United States 37203
    28 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    29 Texas Oncology-Fort Worth Cancer Center Fort Worth Texas United States 76104
    30 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    31 MD Anderson Houston Texas United States 77030
    32 Oncology Consultants - Texas Houston Texas United States 77030
    33 Texas Oncology Odessa-West Texas Cancer Center Odessa Texas United States 79761
    34 Texas Oncology San Antonio Northeast San Antonio Texas United States 78217
    35 NorthWest Medical Specialties, PLLC Tacoma Washington United States 98405
    36 Aurora Research Institute Wauwatosa Wisconsin United States 53226
    37 Hospital Aleman Buenos Aires Argentina C1118AAT
    38 Centro Oncológico Korben Ciudad Autonoma de Buenos Aires Argentina C1426AGE
    39 Instituto Fleni Ciudad Autonoma de Buenos Aires Argentina C1428AQK
    40 CEMIC Saavedra Ciudad Autonoma de Buenos Aires Argentina C1431FWN
    41 Instituto de Investigaciones Metabólicas Ciudad Autónoma de Buenos Aires Argentina C1012AAR
    42 Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Cordoba Argentina 5000
    43 Hospital Italiano de La Plata La Plata Lpl Lpl Argentina 1900
    44 Instituto de Investigaciones Clinicas Mar del Plata Mar Del Plata, Buenos Aires Argentina B7600FZN
    45 Hospital Privado de Comunidad Mar Del Plata Argentina B7602CBM
    46 Hospital Universitario Austral Pilar Argentina 1629
    47 Sanatorio Britanico de Rosario Rosario Argentina 2000
    48 ARS Médica San Salvador De Jujuy Argentina Y4600AFW
    49 Flinders Centre for Innovation in Cancer Adelaide Australia 5042
    50 Chris O'Brien Lifehouse Camperdown Australia 2050
    51 St. Vincent's Hospital Sydney Darlinghurst Australia 2010
    52 St Vincents Hospital Melbourne Melbourne Australia 3065
    53 Fiona Stanley Hospital Murdoch Australia 6150
    54 Perth Children's Hospital Nedlands Australia 6909
    55 Sydney Children'S Hospital Randwick Australia 2031
    56 Intergrated Clinical Oncology Network Pty Ltd (ICON) South Brisbane Australia 4101
    57 Royal Children's Hospital VIC Australia 3052
    58 AZ Klina Brasschaat Belgium 2930
    59 UCL Hopital Saint-Luc Bruxelles Belgium 1200
    60 Grand Hôpital de Charleroi, site Notre Dame Charleroi Belgium 6000
    61 CHU UCL Namur - Site Dinant Dinant Belgium 5500
    62 UZA Edegem Belgium 2650
    63 AZ Maria Middelares Gent Belgium 9000
    64 UZ Gent Gent Belgium 9000
    65 Jolimont Haine-Saint-Paul, La Louviere Belgium 7100
    66 CHU UCL Namur - Site Sainte Elisabeth Namur Belgium 5000
    67 Cliniques St Pierre Ottignies Belgium 1340
    68 CHU UCL Namur - Site Godinne Yvoir Belgium 5530
    69 Hospital de Câncer de Barretos Barretos Brazil 14784-400
    70 Centro Infantil Boldrini Campinas Brazil 13083-210
    71 Hospital Erasto Gaertner - CEPEP Curitiba Brazil 81520-060
    72 Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Goiânia Brazil 74605-070
    73 Hospital de Caridade de Ijui Ijuí Brazil 98700-000
    74 Liga Norte Riograndense Contra O Cancer Natal Brazil 59075-740
    75 Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil
    76 Instituto de Medicina Integral Professor Fernando Figueira Recife Brazil 50070-550
    77 Oncoclínicas Rio De Janeiro Brazil 22250-905
    78 Instituto D'Or de Pesquisa e Ensino (IDOR) Rio de Janeiro Brazil 22281-100
    79 Hospital Sao Rafael Salvador Brazil 41253-190
    80 Instituto do Cancer do Estado de Sao Paulo ICESP Sao Paulo Brazil 01246-000
    81 Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes São Paulo Brazil 01308-050
    82 BP - Beneficencia Portuguesa de São Paulo São Paulo Brazil 01321-001
    83 Fundação Antônio Prudente - A.C. Camargo Cancer Center São Paulo Brazil 01509-900
    84 Itaci (Hc Fm Usp) São Paulo Brazil 05410-030
    85 GRAACC São Paulo Brazil 4039001
    86 CEDOES Vitoria Brazil 29055450
    87 Hospital For Sick Children Toronto Ontario Canada M5G 1X8
    88 Montreal Children's Hospital Montreal Quebec Canada H4A 3J1
    89 Cancer Hospital Chinese Academy of Medical Sciences Beijing China 100021
    90 Beijing Tiantan Hospital, Capital Medical University Beijing China 100070
    91 Peking University Third Hospital Beijing China 100191
    92 Peking Union Medical College Hospital Beijing China 100730
    93 Chinese PLA General Hospital Beijing China 100853
    94 Beijing Luhe Hospital, Capital Medical University Beijing China 101100
    95 Jilin cancer hospital Changchun China 130012
    96 The First Hospital of Jilin University Changchun China 130021
    97 Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College Changsha China 410008
    98 West China Hospital,Sichuan University Chengdu China 610041
    99 Chongqing Southwest Hospital Chongqing China 400038
    100 Third Military Medical University Daping Hospital Cancer Center Chongqing China 400042
    101 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou China 510289
    102 First affiliated Hospital of Zhejiang University Hangzhou China 310003
    103 Zhejiang Cancer Hospital Hangzhou China 310022
    104 Eastern Theater General Hospital, Qinhuai District Medical Area Nanjing China 210002
    105 The First Affiliated Hospital of Nanjing Medical University Nanjing China 210029
    106 Ruijin Hospital, Shanghai Jiao Tong University Shanghai China 200025
    107 Cancer Hospital, FuDan University Shanghai China 200032
    108 Fudan University Shanghai Cancer Center Shanghai China 200032
    109 Shanghai Zhongshan Hospital Shanghai China 200032
    110 Huashan Hospital Fudan University Shanghai China 200040
    111 Shenzhen university General Hospital Shenzhen China 518055
    112 Tianjin cancer hospital Tianjin China 300060
    113 Hopital Saint André Bordeaux France 33075
    114 Centre Francois Baclesse Caen France 14000
    115 Centre Jean Perrin Clermont Ferrand France 63011
    116 Centre Georges François Leclerc Dijon France 21000
    117 Centre Oscar Lambret Lille France 59020
    118 Centre Leon Bérard Lyon France 69008
    119 Hopital de la Timone Marseille France 130005
    120 Institut Regional du Cancer de Montpellier Val d'Aurelle Montpellier France 34298
    121 Institut Curie Paris France 75005
    122 CHU De Poitiers Poitiers France 86021
    123 Institut de Cancérologie de Lorraine Vandoeuvre lès Nancy France 54519
    124 Institut Gustave Roussy Villejuif France 94800
    125 Charité Berlin Germany 10115
    126 Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden Dresden Germany 01307
    127 Universitaetsklinikum Essen Essen Germany 45147
    128 Universitaetsklinikum Frankfurt Frankfurt Germany 60385
    129 Asklepios Klinik Altona Hamburg Germany 22763
    130 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    131 Universitaetsklinikum Koeln Köln Germany 50937
    132 Universitatsklinikum Leipzig Leipzig Germany 04103
    133 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    134 Klinikum rechts der Isar der TU Munchen München Germany 81675
    135 Universitätsklinikum Tübingen Tübingen Germany 72076
    136 Universitätsklinikum Würzburg Wurzburg Germany 97080
    137 Istituto Ortopedico Rizzoli Bologna Italy 40136
    138 A.O.U Sant'Orsola-Malpighi Bologna Italy 40138
    139 Ospedale Policlinico San Martino IRCCS Genova Italy 16132
    140 IRCCS Ospedale San Raffaele Milano Italy 20132
    141 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    142 ASST Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    143 ASST di Monza Monza Italy 20900
    144 Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli Napoli Italy 80138
    145 Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS Napoli Italy 80138
    146 Ospedale S. Maria Della Misericordia Perugia Italy 06132
    147 Ospedale Santa Chiara AO Universitaria Pisana Pisa Italy 56126
    148 IRCCS Ospedale Pediatrico Bambino Gesu Roma Italy 00165
    149 Azienda Ospedaliera S. Maria Terni Terni Italy 5100
    150 Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino Italy 10126
    151 Ospedale Borgo Roma Verona Italy 37134
    152 National Cancer Center Hospital Chuo-Ku Japan 104-0045
    153 Hiroshima University Hospital Hiroshima-shi Japan 734-8551
    154 National Cancer Center Hospital East Kashiwa Japan 277-8577
    155 National Hospital Organizaiton Shikoku Cancer Center Matsuyama Japan 791-0280
    156 Fujita Health University Hospital Toyoake Japan 470-1192
    157 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    158 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    159 Asan Medical Center Seoul Korea, Republic of 05505
    160 Asan Medical Center Seoul Korea, Republic of 05505
    161 Samsung Medical Center Seoul Korea, Republic of 06351
    162 Samsung Medical Center Seoul Korea, Republic of 06351
    163 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    164 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    165 Seoul National University Hospital Seoul Korea, Republic of 3080
    166 Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Bydgoszcz Poland 85-796
    167 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    168 Przychodnia Lekarska KOMED Roman Karaszewski Konin Poland 62-500
    169 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Krakow Poland 31-501
    170 Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz Poland 93-513
    171 Centrum Medyczne Pratia Poznan Skorzewo Poland 60-185
    172 Instytut Matki i Dziecka Warszawa Poland 01-211
    173 Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa Poland 02-507
    174 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    175 Hosp. Univ. de Cruces Barakaldo Spain 48903
    176 Hosp. Univ. Quiron Dexeus Barcelona Spain 08028
    177 Hosp. Univ. Vall D Hebron Barcelona Spain 08035
    178 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    179 Hosp. Sant Joan de Deu Barcelona Spain 08950
    180 Inst. Cat. Doncologia-H Duran I Reynals Hospitalet de Llobregat, Barcelona Spain 08908
    181 Hosp. Infantil Univ. Niño Jesus Madrid Spain 28009
    182 Clinica Univ. de Navarra Madrid Spain 28027
    183 Hosp. Univ. Ramon Y Cajal Madrid Spain 28034
    184 Hosp. Univ. Fund. Jimenez Diaz Madrid Spain 28040
    185 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    186 Hosp. Univ. La Paz Madrid Spain 28046
    187 Hosp. Virgen Del Rocio Sevilla Spain 41013
    188 Hosp. Clinico Univ. de Valencia Valencia Spain 46010
    189 Changhua Christian Hospital Changhua Taiwan 50006
    190 E-Da Cancer Hospital Kaohsiung City Taiwan 82445
    191 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    192 Chang Gung Medical Foundation Kaohsiung Taiwan 833
    193 China Medical University Hospital Taichung Taiwan 403
    194 Taichung Veterans General Hospital Taichung Taiwan 40705
    195 Chi Mei Medical Center - Yong Kang Tainan Taiwan 710
    196 National Cheng Kung University Hospital Tainan Taiwan 710
    197 Chi Mei Medical Center - Liu Ying Tainan Taiwan 736
    198 National Taiwan University Hospital Taipei Taiwan 10002
    199 Taipei Veterans General Hospital Taipei Taiwan 11217
    200 Chang Gung Memorial Hospital Linkou Branch Taoyuan City Taiwan 333
    201 Bristol Royal Hospital for Children Bristol United Kingdom BS2 8AE
    202 Bristol Haematology and Oncology Centre Bristol United Kingdom BS2 8ED
    203 Great Ormond Street Hospital London United Kingdom WC1N 3JH
    204 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    205 Freeman Hospital Newcastle United Kingdom NE7 7DN
    206 Derriford Hospital Plymouth United Kingdom PL6 8DH
    207 The Royal Marsden NHS Trust Sutton United Kingdom SM2 5PT
    208 The Clatterbridge Cancer Centre Wirral United Kingdom CH63 4JY

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04083976
    Other Study ID Numbers:
    • CR108661
    • 2019-002113-19
    • 42756493CAN2002
    First Posted:
    Sep 10, 2019
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jun 21, 2022