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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
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

Full criteria on ClinicalTrials.gov

Sites (156)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituto de Investigaciones Metabolicas
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Buenos AiresArgentinaUnknown status
Hospital Alemán
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Buenos AiresArgentinaUnknown status
Centro Oncologico Korben
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Buenos AiresArgentinaUnknown status
CEMIC Saavedra
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Buenos AiresArgentinaUnknown status
Instituto Fleni
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Buenos AiresArgentinaUnknown status
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaUnknown status
Hospital Italiano de La Plata
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La Plata Lpl LplArgentinaUnknown status
Hospital Privado de Comunidad
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Mar del PlataArgentinaUnknown status
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaUnknown status
Hospital Universitario Austral
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PilarArgentinaUnknown status
Sanatorio Británico de Rosario
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RosarioArgentinaUnknown status
ARS Médica
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San Salvador de JujuyArgentinaUnknown status
Flinders Centre for Innovation in Cancer
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AdelaideAustraliaUnknown status
Chris O'Brien Lifehouse
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CamperdownAustraliaUnknown status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Intergrated Clinical Oncology Network Pty Ltd (ICON)
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South BrisbaneAustraliaUnknown status
AZ KLINA
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BrasschaatBelgiumUnknown status
UCL Hopital Saint-Luc
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BrusselsBelgiumUnknown status
Grand Hopital de Charleroi - Site Notre Dame
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CharleroiBelgiumUnknown status
CHU UCL Namur - Site Dinant
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DinantBelgiumUnknown status
UZA
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EdegemBelgiumUnknown status
AZ Maria Middelares
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GhentBelgiumUnknown status
UZ Gent
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GhentBelgiumUnknown status
Jolimont
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Haine-Saint-PaulBelgiumUnknown status
CHU UCL Namur / Site Sainte Elisabeth
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NamurBelgiumUnknown status
Cliniques St Pierre
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OttigniesBelgiumUnknown status
CHU UCL Namur - Site Godinne
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YvoirBelgiumUnknown status
Fundacao Pio XII
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BarretosBrazilUnknown status
Liga Paranaense de Combate ao Cancer
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CuritibaBrazilUnknown status
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
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GoiâniaBrazilUnknown status
Associação Hospital de Caridade Ijuí
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IjuíBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto de Medicina Integral Professor Fernando Figueira
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RecifeBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Instituto D Or de Pesquisa e Ensino IDOR
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Rio de JaneiroBrazilUnknown status
Hospital Sao Rafael
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SalvadorBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilUnknown status
GRAACC
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da USP
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São PauloBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Beijing Luhe Hospital, Capital Medical University
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BeijingChinaUnknown status
Chinese PLA General Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Beijing Tiantan Hospital,Capital Medical University
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing Southwest Hospital
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ChongqingChinaUnknown status
Third Military Medical University Daping Hospital Cancer Center
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ChongqingChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Eastern Theater General Hospital, Qinhuai District Medical Area
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NanjingChinaUnknown status
Cancer hospital Fudan University
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ShanghaiChinaUnknown status
Shanghai Zhongshan Hospital
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyCompleted
Hospital Infantil Universitario Nino Jesus
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MadridSpainCompleted
Hôpital Saint-André
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BordeauxFranceUnknown status
Centre François Baclesse
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CaenFranceUnknown status
Centre Jean Perrin
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Clermont-FerrandFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
Centre Oscar Lambret
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LilleFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Hopital de la Timone
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MarseilleFranceUnknown status
Institut Curie
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ParisFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceUnknown status
Institut Gustave Roussy
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VillejuifFranceUnknown status
Bristol Haematology and Oncology Centre
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BristolUnited KingdomUnknown status
Bristol Royal Hospital for Children
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BristolUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
The Clatterbridge Cancer Centre
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Metropolitan Borough of WirralUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
The Royal Marsden NHS Trust
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SuttonUnited KingdomUnknown status
Istituto Ortopedico Rizzoli
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BolognaItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
Asst Di Monza
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MonzaItalyUnknown status
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
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NaplesItalyUnknown status
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
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NaplesItalyUnknown status
Ospedale S. Maria della Misericordia
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PerugiaItalyUnknown status
Ospedale Santa Chiara AO Universitaria Pisana
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PisaItalyUnknown status
Azienda Ospedaliera S.Maria - Terni
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TerniItalyUnknown status
Ospedale Borgo Roma
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VeronaItalyUnknown status
National Cancer Center Hospital
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ChūōkuJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Fujita Health University Hospital
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ToyoakeJapanUnknown status
Severance Hospital Yonsei University Health System 2
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SeoulSouth KoreaUnknown status
Severance Hospital Yonsei University Health System 1
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SeoulSouth KoreaUnknown status
Samsung Medical Center 1
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SeoulSouth KoreaUnknown status
Asan Medical Center 2
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital 1
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SeoulSouth KoreaUnknown status
Asan Medical Center 1
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Samsung Medical Center 2
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
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BydgoszczPolandUnknown status
Przychodnia Lekarska Komed Roman Karaszewski
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KoninPolandUnknown status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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KrakowPolandUnknown status
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandUnknown status
Centrum Medyczne Pratia Poznan
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SkórzewoPolandUnknown status
Centralny Szpital Kliniczny MSWiA w Warszawie
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WarsawPolandUnknown status
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandUnknown status
Instytut Matki i Dziecka
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WarsawPolandUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
E-Da Cancer Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Medical Foundation
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Chi Mei Medical Center Yong Kang
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TainanTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Medical Center Liu Ying
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital Linkou Branch
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Taoyuan CityTaiwanUnknown status
Hawaii Cancer Care
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‘AieaUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Levine Cancer Institute, Carolinas HealthCare System
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CharlotteUnited StatesUnknown status
Tennessee Oncology, PLLC
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ChattanoogaUnited StatesUnknown status
Oncology Hematology Care
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CincinnatiUnited StatesUnknown status
Rocky Mountain Cancer Centers
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Colorado SpringsUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Texas Oncology - Fort Worth Cancer Center
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Fort WorthUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Memorial Cancer Institute
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HollywoodUnited StatesUnknown status
MD Anderson
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HoustonUnited StatesUnknown status
Oncology Consultants Texas
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HoustonUnited StatesUnknown status
Cancer Specialists of North Florida
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JacksonvilleUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Mount Sinai
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New YorkUnited StatesUnknown status
Texas Oncology Odessa-West Texas Cancer Center
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OdessaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
Texas Oncology San Antonio Northeast
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San AntonioUnited StatesUnknown status
Maine Medical Center
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ScarboroughUnited StatesUnknown status
Northwest Medical Specialties PLLC
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TacomaUnited StatesUnknown status
Arizona Oncology Associates, PC - HOPE
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TucsonUnited StatesUnknown status
Aurora Research Institute
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WauwatosaUnited StatesUnknown status

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