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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

BRIEF SUMMARY

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

DETAILED DESCRIPTION

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

  • 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: Participate-In-This-Study@its.jnj.com

LOCATION

Facility Status Contact
Facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Buenos Aires, British Columbia C1419AHN
Argentina
Status: Recruiting Contact: N/A
Facility: CEMIC Saavedra
Ciudad Autonoma de Buenos Aires, British Columbia C1431FWN
Argentina
Status: Recruiting Contact: N/A
Facility: Centro Oncológico Korben
Ciudad Autónoma de Buenos Aires, Manitoba C1426AGE
Argentina
Status: Recruiting Contact: N/A
Facility: Centro Urologico Profesor Bengio
Cordoba, Ontario X5000KPH
Argentina
Status: Recruiting Contact: N/A
Facility: Hospital Privado de Comunidad
Mar Del Plata, Saskatchewan B7602CBM
Argentina
Status: Recruiting Contact: N/A
Facility: Centro de Investigacion Pergamino SA
Pergamino, B2700CPM
Argentina
Status: Recruiting Contact: N/A
Facility: Fundacao Pio XII
Barretos, 14784-400
Brazil
Status: Recruiting Contact: N/A
Facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, 30380-472
Brazil
Status: Recruiting Contact: N/A
Facility: Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060
Brazil
Status: Recruiting Contact: N/A
Facility: Clínica de Neoplasias Litoral Ltda.
Itajai, 88301-220
Brazil
Status: Recruiting Contact: N/A
Facility: Fundacao Doutor Amaral Carvalho
Jau, 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: Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Nossa Senhora da Conceicao S.A
Porto Alegre, 91350-200
Brazil
Status: Recruiting Contact: N/A
Facility: Hospital Sao Rafael
Salvador, 41253-190
Brazil
Status: Recruiting Contact: N/A
Facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo Andre, 09060-650
Brazil
Status: Recruiting Contact: N/A
Facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, 15090-000
Brazil
Status: Recruiting Contact: N/A
Facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center
Sao Paulo, 01509900
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
Sorocaba, 18030-005
Brazil
Status: Recruiting Contact: N/A
Facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo, 01308-901
Brazil
Status: Recruiting Contact: N/A
Facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04502-001
Brazil
Status: Recruiting Contact: N/A
Facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05651-900
Brazil
Status: Recruiting Contact: N/A
Facility: Beijing Hospital
Beijing, 100730
China
Status: Recruiting Contact: N/A
Facility: Peking Union Medical College Hospital
Beijing, 100730
China
Status: Recruiting Contact: N/A
Facility: Sichuan Provincial People's Hospital
Chengdu, 610000
China
Status: Recruiting Contact: N/A
Facility: Sichuan University Huaxi Hospital
Chengdu, 610041
China
Status: Recruiting Contact: N/A
Facility: Chongqing University Cancer Hospital
ChongQing, 400030
China
Status: Recruiting Contact: N/A
Facility: Sun Yat-Sen University Cancer Center
Guangzhou, 510060
China
Status: Recruiting Contact: N/A
Facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310020
China
Status: Recruiting Contact: N/A
Facility: Jiangsu Cancer Hospital
Nanjing, 210009
China
Status: Recruiting Contact: N/A
Facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
ShangHai, 200127
China
Status: Recruiting Contact: N/A
Facility: Huadong Hospital Affiliated to Fudan University
Shanghai, 200400
China
Status: Recruiting Contact: N/A
Facility: Shengjing Hospital of China Medical University
Shenyang, 110004
China
Status: Recruiting Contact: N/A
Facility: First Affiliated Hospital of Wenzhou Medical College
Wenzhou, 325000
China
Status: Recruiting Contact: N/A
Facility: The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
China
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie de l'Ouest (ICO)
Angers, 49055
France
Status: Recruiting Contact: N/A
Facility: Hopital Jean MINJOZ
Besancon Cedex, 25030
France
Status: Recruiting Contact: N/A
Facility: Institut Bergonié
Bordeaux, 33000
France
Status: Recruiting Contact: N/A
Facility: CHRU Brest - Hopital Morvan
Brest, 29609
France
Status: Recruiting Contact: N/A
Facility: Centre Jean Perrin
Clermont Ferrand, 63011
France
Status: Recruiting Contact: N/A
Facility: Centre Georges-François Leclerc
Dijon, 21079
France
Status: Recruiting Contact: N/A
Facility: Hôpital Privé Le Bois
Lille, 59000
France
Status: Recruiting Contact: N/A
Facility: Centre Oscar Lambret
Lille, 59020
France
Status: Recruiting Contact: N/A
Facility: Groupe Hospitalier Bretagne Sud
Lorient, 56322
France
Status: Recruiting Contact: N/A
Facility: Hopital de la Timone
Marseille, 13005
France
Status: Recruiting Contact: N/A
Facility: Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298
France
Status: Recruiting Contact: N/A
Facility: Centre Antoine Lacassagne
Nice, 06189
France
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie du Gard
Nîmes, 30029
France
Status: Recruiting Contact: N/A
Facility: Hopital Europeen Georges-Pompidou
Paris, 75015
France
Status: Recruiting Contact: N/A
Facility: Hospices Civils de Lyon HCL
Pierre-Bénite, 69495
France
Status: Recruiting Contact: N/A
Facility: CHU De Poitiers
Poitiers Cedex, 86021
France
Status: Recruiting Contact: N/A
Facility: Centre Eugene Marquis
Rennes Cedex, 35062
France
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271
France
Status: Recruiting Contact: N/A
Facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg Cedex, 67098
France
Status: Recruiting Contact: N/A
Facility: Institut Claudius Regaud
Toulouse, 31059
France
Status: Recruiting Contact: N/A
Facility: Centre Les Dentellieres
Valenciennes, 59300
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 94805
France
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Duesseldorf
Duesseldorf, 40225
Germany
Status: Recruiting Contact: N/A
Facility: Friedrich-Alexander Universitaet Urologische Universitaetskl
Erlangen, 91054
Germany
Status: Recruiting Contact: N/A
Facility: Universitatsklinikum Frankfurt
Frankfurt, 60590
Germany
Status: Recruiting Contact: N/A
Facility: Asklepios Klinik Altona
Hamburg, 22763
Germany
Status: Recruiting Contact: N/A
Facility: Medizinische Hochschule Hannover
Hannover, 30625
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Schleswig Holstein Campus Lübeck
Lubeck, 23538
Germany
Status: Recruiting Contact: N/A
Facility: Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, 68167
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsklinikum Muenster
Muenster, 48149
Germany
Status: Recruiting Contact: N/A
Facility: Studienpraxis Urologie Drs. Feyerabend
Nuertingen, 72622
Germany
Status: Recruiting Contact: N/A
Facility: Caritas-Krankenhaus St. Josef
Regensburg, 93053
Germany
Status: Recruiting Contact: N/A
Facility: Universitaetsmedizin Rostock
Rostock, 18057
Germany
Status: Recruiting Contact: N/A
Facility: Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály
Budapest, 1122
Hungary
Status: Recruiting Contact: N/A
Facility: Uzsoki Utcai Korhaz
Budapest, H-1145
Hungary
Status: Recruiting Contact: N/A
Facility: Rambam Health Care Campus
Haifa, 31096
Israel
Status: Recruiting Contact: N/A
Facility: Hadassah Medical Center
Jerusalem, 91120
Israel
Status: Recruiting Contact: N/A
Facility: Rabin Medical Center, Beilinson Hospital
Petach Tikvah, 49100
Israel
Status: Recruiting Contact: N/A
Facility: Medicos Especialistas en Cancer, S.C.
Aguascalientes, 31000
Mexico
Status: Recruiting Contact: N/A
Facility: Oncologia Integral Satelite
Naucalpan, 1066 CX
Mexico
Status: Recruiting Contact: N/A
Facility: Hospital Lusíadas
Lisboa, 1649-035
Portugal
Status: Recruiting Contact: N/A
Facility: Chlc - Hosp. Sto Antonio Dos Capuchos
Lisboa, 1400-038
Portugal
Status: Recruiting Contact: N/A
Facility: Champalimaud Foundation Champalimaud Centre
Lisbon, 4200072
Portugal
Status: Recruiting Contact: N/A
Facility: Instituto Portugues de Oncologia
Porto, 656049
Portugal
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Infanta Cristina
Badajoz, 08916
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol
Badalona, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Clinic I Provincial de Barcelona
Barcelona, 08041
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. de La Santa Creu I Sant Pau
Barcelona, 10003
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. San Pedro de Alcantara
Cáceres, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Reina Sofia
Córdoba, 18014
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Virgen de Las Nieves
Granada, 23007
Spain
Status: Recruiting Contact: N/A
Facility: Complejo Hospitalario de Jaen
Jaén, 35016
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria, 27003
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Lucus Augusti
Lugo, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. La Paz
Madrid, 28051
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. 12 de Octubre
Madrid, 28220
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 08243
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, 41009
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen Macarena
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen Del Rocio
Sevilla, 46014
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Gral. Univ. Valencia
Valencia, 46026
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. I Politecni La Fe
Valencia, 50009
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Miguel Servet
Zaragoza, 807
Spain
Status: Recruiting Contact: N/A
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 833
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang Gung Medical Foundation
Niao-Sung Hsiang, 40447
Taiwan
Status: Recruiting Contact: N/A
Facility: China Medical University Hospital
Taichung, 40705
Taiwan
Status: Recruiting Contact: N/A
Facility: Taichung Veterans General Hospital
Taichung, 70403
Taiwan
Status: Recruiting Contact: N/A
Facility: National Cheng Kung University Hospital
Tainan, 710
Taiwan
Status: Recruiting Contact: N/A
Facility: Chi Mei Medical Center - Yong Kang
Tainan, 10002
Taiwan
Status: Recruiting Contact: N/A
Facility: Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 333
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 01120
Taiwan
Status: Recruiting Contact: N/A