NCT04083976CompletedPhase 2
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 316 (actual)
- First submitted
- 6 Sept 2019
- Start date
- 20 Nov 2019
- Primary completion date
- 4 Dec 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Childhood cancers
- NCT number
- NCT04083976
- EU CT number
- 2023-510301-18-00
- EudraCT number
- 2019-002113-19
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 316
- From 20 Nov 2019 to the primary completion date, 4 Dec 2023
- 156 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
- Active malignancies other than for disease requiring therapy
Lab values
- 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
Other
- The presence of FGFR gatekeeper and resistance mutations
- Histologic demonstration of urothelial carcinoma
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (156)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Investigaciones Metabolicas Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Alemán Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Oncologico Korben Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CEMIC Saavedra Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Fleni Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Hospital Italiano de La Plata Coordinator of this site? Confirm its status | La Plata Lpl Lpl | Argentina | Unknown status |
| Hospital Privado de Comunidad Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Hospital Universitario Austral Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Sanatorio Británico de Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| ARS Médica Coordinator of this site? Confirm its status | San Salvador de Jujuy | Argentina | Unknown status |
| Flinders Centre for Innovation in Cancer Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Intergrated Clinical Oncology Network Pty Ltd (ICON) Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| AZ KLINA Coordinator of this site? Confirm its status | Brasschaat | Belgium | Unknown status |
| UCL Hopital Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Grand Hopital de Charleroi - Site Notre Dame Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| CHU UCL Namur - Site Dinant Coordinator of this site? Confirm its status | Dinant | Belgium | Unknown status |
| UZA Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Jolimont Coordinator of this site? Confirm its status | Haine-Saint-Paul | Belgium | Unknown status |
| CHU UCL Namur / Site Sainte Elisabeth Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| Cliniques St Pierre Coordinator of this site? Confirm its status | Ottignies | Belgium | Unknown status |
| CHU UCL Namur - Site Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Liga Paranaense de Combate ao Cancer Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Associação Hospital de Caridade Ijuí Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto de Medicina Integral Professor Fernando Figueira Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Oncoclinicas Rio de Janeiro S A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto D Or de Pesquisa e Ensino IDOR Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Sao Rafael Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Real e Benemerita Associacao Portuguesa de Beneficencia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| GRAACC Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundacao Antonio Prudente A C Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Beijing Luhe Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Southwest Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Third Military Medical University Daping Hospital Cancer Center Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Eastern Theater General Hospital, Qinhuai District Medical Area Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Cancer hospital Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hôpital Saint-André Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Bristol Haematology and Oncology Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Bristol Royal Hospital for Children Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| The Royal Marsden NHS Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Istituto Ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Asst Di Monza Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fondazione G Pascale Istituto Nazionale Tumori IRCCS Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale S. Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Ospedale Santa Chiara AO Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Azienda Ospedaliera S.Maria - Terni Coordinator of this site? Confirm its status | Terni | Italy | Unknown status |
| Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Severance Hospital Yonsei University Health System 2 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital Yonsei University Health System 1 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center 1 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center 2 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital 1 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center 1 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center 2 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Przychodnia Lekarska Komed Roman Karaszewski Coordinator of this site? Confirm its status | Konin | Poland | Unknown status |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Centrum Medyczne Pratia Poznan Coordinator of this site? Confirm its status | Skórzewo | Poland | Unknown status |
| Centralny Szpital Kliniczny MSWiA w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Instytut Matki i Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| E-Da Cancer Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Medical Foundation Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Chi Mei Medical Center Yong Kang Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chi Mei Medical Center Liu Ying Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Linkou Branch Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Hawaii Cancer Care Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Levine Cancer Institute, Carolinas HealthCare System Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Tennessee Oncology, PLLC Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Oncology Hematology Care Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Texas Oncology - Fort Worth Cancer Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Memorial Cancer Institute Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Oncology Consultants Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Texas Oncology Odessa-West Texas Cancer Center Coordinator of this site? Confirm its status | Odessa | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Texas Oncology San Antonio Northeast Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Maine Medical Center Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| Northwest Medical Specialties PLLC Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Arizona Oncology Associates, PC - HOPE Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Aurora Research Institute Coordinator of this site? Confirm its status | Wauwatosa | United States | Unknown status |
Related publications
- Erdafitinib in Patients With Advanced Solid Tumors With FGFR Alterations (RAGNAR): Results of Tumor-Specific Analyses and Secondary Cohorts.JCO Precis Oncol · 2026 · PMID 42456086
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