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

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Erdafitinib

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 participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered as the time when the last participant receives the last dose of study drug on the study and either all pediatric participants are off study or until the most recently enrolled pediatric participant still participating in the study has 6 months of follow-up, whichever occurs first. Currently this study is recruiting pediatric participants only.

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabólicas
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncológico Korben
  • Buenos Aires, Argentina, C1428AQK
    • Instituto Fleni
  • Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • La Plata Lpl Lpl, Argentina, 1900
    • Hospital Italiano de La Plata
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Mar del Plata, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas Mar del Plata
  • Pilar, Argentina, 1629
    • Hospital Universitario Austral
  • Rosario, Argentina, 2000
    • Sanatorio Britanico de Rosario
  • San Salvador de Jujuy, Argentina, Y4600AFW
    • ARS Médica
• Australia
  • Adelaide, Australia, 5042
    • Flinders Centre for Innovation in Cancer
  • Camperdown, Australia, 2050
    • Chris O'Brien Lifehouse
  • Darlinghurst, Australia, 2010
    • St Vincent s Hospital Sydney
  • Fitzroy, Australia, 3065
    • St Vincents Hospital Melbourne
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • South Brisbane, Australia, 4101
    • Intergrated Clinical Oncology Network Pty Ltd (ICON)
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brussels, Belgium, 1200
    • UCL Hopital Saint-Luc
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Dinant, Belgium, 5500
    • CHU UCL Namur - Site Dinant
  • Edegem, Belgium, 2650
    • UZA
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Ghent, Belgium, 9000
    • UZ Gent
  • Haine-Saint-Paul, Belgium, 7100
    • Jolimont
  • Namur, Belgium, 5000
    • CHU UCL Namur - Site Sainte Elisabeth
  • Ottignies, Belgium, 1340
    • Cliniques St Pierre
  • Yvoir, Belgium, 5530
    • CHU UCL Namur - Site Godinne
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundacao Pio XII
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Goiânia, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ijuí, Brazil, 98700-000
    • Associacao Hospital de Caridade Ijui
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Recife, Brazil, 50070-550
    • Instituto de Medicina Integral Professor Fernando Figueira
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 22281 100
    • Instituto D Or de Pesquisa e Ensino IDOR
  • Salvador, Brazil, 41253 190
    • Hospital Sao Rafael
  • São Paulo, Brazil, 01321-001
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • São Paulo, Brazil, 05410-030
    • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • São Paulo, Brazil, 4039001
    • GRAACC
  • São Paulo, Brazil, 01308 901
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
• China
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100070
    • Beijing Tiantan Hospital, Capital Medical University
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 101100
    • Beijing Luhe Hospital, Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 130012
    • Jilin Cancer Hospital
  • Chengdu, China, 610041
    • West China Hospital,Sichuan University
  • Chongqing, China, 400038
    • Chongqing Southwest Hospital
  • Chongqing, China, 400042
    • Third Military Medical University Daping Hospital Cancer Center
  • Guangzhou, China, 510289
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310003
    • First affiliated Hospital of Zhejiang University
  • Nanjing, China, 210002
    • Eastern Theater General Hospital, Qinhuai District Medical Area
  • Shanghai, China, 200032
    • Shanghai Zhongshan Hospital
  • Shanghai, China, 200032
    • Cancer Hospital, FuDan University
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • Shanghai, China, 200025
    • Ruijin Hospital Shanghai Jiao Tong University
• France
  • Bordeaux, France, 33075
    • Hopital Saint André
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 130005
    • Hopital de la Timone
  • Paris, France, 75005
    • Institut Curie
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10115
    • Charité
  • Cologne, Germany, 50937
    • Universitaetsklinikum Koeln
  • Dresden, Germany, 01307
    • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Frankfurt, Germany, 60385
    • Universitaetsklinikum Frankfurt
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg 1
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Mainz, Germany, 55131
    • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München
  • Tübingen, Germany, 72076
    • Universitatsklinikum Tubingen
• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Monza, Italy, 20900
    • Asst Di Monza
  • Naples, Italy, 80138
    • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  • Naples, Italy, 80138
    • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
  • Perugia, Italy, 06132
    • Ospedale S. Maria Della Misericordia
  • Pisa, Italy, 56126
    • Ospedale Santa Chiara AO Universitaria Pisana
  • Terni, Italy, 5100
    • Azienda Ospedaliera S. Maria Terni
  • Verona, Italy, 37134
    • Ospedale Borgo Roma
• Japan
  • Chūōku, Japan, 104 0045
    • National Cancer Center Hospital
  • Hiroshima, Japan, 734 8551
    • Hiroshima University Hospital
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Matsuyama, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
• Poland
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED Roman Karaszewski
  • Krakow, Poland, 31 501
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 93 513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Skorzewo, Poland, 60 185
    • Centrum Medyczne Pratia Poznan
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warsaw, Poland, 01 211
    • Instytut Matki i Dziecka
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
• South Korea
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center 1
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System 1
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System 2
  • Seoul, South Korea, 05505
    • Asan Medical Center 2
  • Seoul, South Korea, 06351
    • Samsung Medical Center 1
  • Seoul, South Korea, 06351
    • Samsung Medical Center 2
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital 1
• Spain
  • Barcelona, Spain, 08028
    • Hosp. Univ. Quiron Dexeus
  • Barcelona, Spain, 08950
    • Hosp. Sant Joan de Deu
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • L'Hospitalet de Llobregat, Spain, 08908
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28027
    • Clinica Univ. de Navarra
  • Madrid, Spain, 28009
    • Hosp. Infantil Univ. Nino Jesus
  • Madrid, Spain, 28040
    • Hosp Univ Fund Jimenez Diaz
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 82445
    • E-Da Cancer Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Medical Foundation
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 403
    • China Medical University Hospital
  • Tainan, Taiwan, 710
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center Yong Kang
  • Tainan, Taiwan, 736
    • Chi Mei Medical Center Liu Ying
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Bristol, United Kingdom, BS2 8AE
    • Bristol Royal Hospital for Children
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Trust
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC - HOPE
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
  • Georgia
    • Atlanta, Georgia, United States, 30022
      • Emory University
  • Hawaii
    • ‘Aiea, Hawaii, United States, 96701
      • Hawaii Cancer Care
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
    • New York, New York, United States, 10128
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute, Carolinas HealthCare System
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology Baylor Charles A Sammons Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology-Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • MD Anderson
    • Houston, Texas, United States, 77030
      • Oncology Consultants Texas
    • Odessa, Texas, United States, 79761
      • Texas Oncology Odessa-West Texas Cancer Center
    • San Antonio, Texas, United States, 78217
      • Texas Oncology San Antonio Northeast
  • Washington
    • Tacoma, Washington, United States, 98405
      • NorthWest Medical Specialties, PLLC
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Broad Panel and Pediatric Cohorts: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC)	ORR is defined as the percentage of participants who achieved a complete response (CR), or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) criteria. According to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions; PR: sum of products of diameters [SPD] decreased by >=50 percent [%] from baseline value) and clinical performance status with steroid dose information.	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years
Core Panel Cohort: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC)	ORR is defined as the percentage of participants who achieved a CR, or PR based on RANO criteria. According to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions; PR: sum of products of diameters [SPD] decreased by >=50 percent [%] from baseline value) and clinical performance status with steroid dose information. The core panel cohort is a subgroup of the broad panel cohort with a select panel of pre-specified FGFR markers: FGFR3 mutations (S249C;Y373C; R248C; G370C); FGFR2 mutations (C382R); FGFR3 fusions (FGFR3-TACC3); FGFR2 fusions (FGFR2-BICC1; FGFR2-TACC2).	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR) as Assessed by Investigators Assessment	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Duration of Responses (DOR)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Disease Control Rate (DCR)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Clinical Benefit Rate (CBR)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Progression-free Survival (PFS)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Overall Survival (OS)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Number of Participants With Adverse Events (AEs)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Number of Participants With Adverse Events (AEs) by Severity	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Pediatric Cohort: Plasma Concentration of Erdafitinib	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) for Participants >=18 Years	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Change From Baseline in Pediatric Functional Assessment Of Cancer Therapy-Brain (Peds FACT-Br)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Change From Baseline in Patient Global Impression of Symptom Severity (PGIS)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Change From Baseline in Patient Global Impression of Change (PGIC)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Change From Baseline in European Quality of Life -5 Dimensions-5 Levels (EQ-5D-5L)	Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pant S, Schuler M, Iyer G, Witt O, Doi T, Qin S, Tabernero J, Reardon DA, Massard C, Minchom A, Lugowska I, Carranza O, Arnold D, Gutierrez M, Winter H, Stuyckens K, Crow L, Najmi S, Hammond C, Thomas S, Santiago-Walker A, Triantos S, Sweiti H, Loriot Y; RAGNAR Investigators. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study. Lancet Oncol. 2023 Aug;24(8):925-935. doi: 10.1016/S1470-2045(23)00275-9.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; erdafitinib
• Other Study ID Numbers: CR108661; 2019-002113-19 (EudraCT Number); 42756493CAN2002 (Other Identifier: Janssen Research & Development, LLC); 2023-510301-18-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No