Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT ID: NCT05052801

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2026-06-20

Brief Summary

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The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Detailed Description

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Conditions

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Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bemarituzumab with mFOLFOX6

Group Type EXPERIMENTAL

Bemarituzumab

Intervention Type DRUG

Intravenous (IV) infusion

mFOLFOX6

Intervention Type DRUG

mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Placebo with mFOLFOX6

Group Type ACTIVE_COMPARATOR

mFOLFOX6

Intervention Type DRUG

mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Placebo

Intervention Type DRUG

IV infusion

Interventions

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Bemarituzumab

Intravenous (IV) infusion

Intervention Type DRUG

mFOLFOX6

mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

Intervention Type DRUG

Placebo

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
* Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
* Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
* Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
* Participant has no contraindications to mFOLFOX6 chemotherapy
* Adequate organ and bone marrow function:

* absolute neutrophil count greater than or equal to 1.5 times 10\^9/L
* platelet count greater than or equal to 100 times 10\^9/L
* hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
* calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\]) × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female)
* international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

Exclusion Criteria

* Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
* Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
* Known human epidermal growth factor receptor 2 (HER2) positive
* Untreated or symptomatic central nervous system (CNS) disease or brain metastases
* Peripheral sensory neuropathy greater than or equal to Grade 2
* Clinically significant cardiac disease
* Other malignancy within the last 2 years (exceptions for definitively treated disease)
* Chronic or systemic ophthalmological disorders
* Major surgery or other investigational study within 28 days prior to first dose of study treatment
* Palliative radiotherapy within 14 days prior to the first dose of study treatment
* Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zai Lab (China only)

UNKNOWN

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Alaska Oncology and Hematology

Anchorage, Alaska, United States

Site Status

Mayo Clinic Arizona

Phoenix, Arizona, United States

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The Oncology Institute Clinical Research

Cerritos, California, United States

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University of California Los Angeles

Los Angeles, California, United States

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Mayo Clinic Florida

Jacksonville, Florida, United States

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Saint Francis Medical Group

Indianapolis, Indiana, United States

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University of Michigan

Ann Arbor, Michigan, United States

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Mayo Clinic Rochester

Rochester, Minnesota, United States

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Healthier Hematology and Oncology Excelsior Integrated Medical Group

Brooklyn, New York, United States

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White Plains Hospital Center for Cancer Care

White Plains, New York, United States

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Levine Cancer Institute University

Charlotte, North Carolina, United States

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FirstHealth Cancer Center

Pinehurst, North Carolina, United States

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Avera Cancer Institute

Sioux Falls, South Dakota, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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Inova Schar Cancer Institute

Fairfax, Virginia, United States

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Medical Oncology Associates, PS

Spokane, Washington, United States

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Instituto Alexander Fleming

CABA, Buenos Aires, Argentina

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Hospital Universitario Fundacion Favaloro

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, Argentina

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Hospital Privado Universitario de Cordoba

Córdoba, Córdoba Province, Argentina

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Hospital Provincial del Centenario

Rosario, Santa Fe Province, Argentina

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Exelsus Oncologia Clinica

San Miguel de Tucumán, Tucumán Province, Argentina

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Instituto Argentino de Diagnostico y Tratamiento IADT

Buenos Aires, , Argentina

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Hospital Britanico de Buenos Aires

Buenos Aires, , Argentina

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Liverpool Hospital

Liverpool, New South Wales, Australia

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St John of God Murdoch Hospital

Murdoch, Western Australia, Australia

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Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

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Universitair Ziekenhuis Gent

Ghent, , Belgium

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Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, , Belgium

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Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, , Belgium

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Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

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Centro de Oncologia Mackenzie

Curitiba, Paraná, Brazil

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Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

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Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

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Clinica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

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Centro de Pesquisa e Ensino em Oncologia de Santa Catarina

Florianópolis, Santa Catarina, Brazil

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Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas

Santo André, São Paulo, Brazil

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Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

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Hospital Nove de Julho - dasa

São Paulo, , Brazil

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Instituto Brasileiro de Controle do Cancer Ibcc

São Paulo, , Brazil

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Multiprofile Hospital for Active Treatment Park Hospital EOOD

Branipole Village, , Bulgaria

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Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

Haskovo, , Bulgaria

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University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD

Pleven, , Bulgaria

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University Multiprofile Hospital for Active Treatment Pulmed OOD

Plovdiv, , Bulgaria

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Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, , Bulgaria

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Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, , Bulgaria

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Cross Cancer Institute

Edmonton, Alberta, Canada

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The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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Jewish General Hospital

Montreal, Quebec, Canada

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James Lind Centro de Investigacion del Cancer

Temuco, Cautín, Chile

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Clinica CIDO

Temuco, Cautín, Chile

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Centro de Estudios Clinicos SAGA Spa

Santiago, , Chile

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Centro de Estudios Clinicos e Investigaciones Medicas CeCim

Santiago, , Chile

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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Anhui Provincial Cancer Hospital

Hefei, Anhui, China

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Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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Fujian Cancer Hospital

Fuzhou, Fujian, China

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The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

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Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

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The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

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Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology

Wuhan, Hebei, China

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

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Anyang Cancer Hospital

Anyang, Henan, China

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The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, China

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Henan Cancer Hospital

Zhengzhou, Henan, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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Taihe Hospital Affiliated Hospital of Hubei University of Medicine

Shiyan, Hubei, China

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The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech

Wuhan, Hubei, China

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Hubei Cancer Hospital

Wuhan, Hubei, China

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Xiangya Hospital of Central South University

Changsha, Hunan, China

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Hunan Cancer Hospital

Changsha, Hunan, China

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Nanjing First Hospital

Nanjing, Jiangsu, China

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The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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The First Hospital of Jilin University

Changchun, Jilin, China

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China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

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The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

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The First Hospital of China Medical University

Shenyang, Liaoning, China

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Liaoning Cancer Hospital

Shenyang, Liaoning, China

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The First Affiliated Hospital of Xi an Jiaotong University

Xi'an, Shaanxi, China

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Jinan Central Hospital

Jinan, Shandong, China

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The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

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Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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Changzhi Peoples Hospital

Changzhi, Shanxi, China

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Linfen Central Hospital

Linfen, Shanxi, China

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Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

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Sichuan Cancer Hospital

Chengdu, Sichuan, China

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The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

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Lishui Municipal central Hospital

Lishui, Zhejiang, China

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The First Affiliate Hospital of Ningbo University

Ningbo, Zhejiang, China

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Peoples Hospital of Quzhou

Quzhou, Zhejiang, China

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Beijing Cancer Hospital

Beijing, , China

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Tianjin Medical University Cancer institute and hospital

Tianjin, , China

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Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

Rionegro, Antioquia, Colombia

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Sociedad de Oncologia y Hematologia del Cesar

Valledupar, Cesar Department, Colombia

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Fundacion Cardiovascular de Colombia

Bucaramanga, Santander Department, Colombia

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Instituto Cancerologico de Narino Ltda

Pasto, , Colombia

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Masarykuv onkologicky ustav

Brno, , Czechia

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Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

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Fakultni nemocnice Olomouc

Olomouc, , Czechia

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Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

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Fakultni Thomayerova nemocnice

Prague, , Czechia

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Rigshospitalet

Copenhagen, , Denmark

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North Estonia Medical Centre Foundation

Tallinn, , Estonia

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Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud

Amiens, , France

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Sainte Catherine - Institut du Cancer d Avignon

Avignon, , France

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Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz

Besançon, , France

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Centre Hospitalier Universitaire de Brest - Cavale Blanche

Brest, , France

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Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing

Clermont-Ferrand, , France

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Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille, , France

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Centre Leon Berard

Lyon, , France

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Hôpital Européen Georges Pompidou

Paris, , France

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Institut Mutualiste Montsouris

Paris, , France

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Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré

Reims, , France

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Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, , France

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Institut de cancerologie Strasbourg Europe

Strasbourg, , France

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Institut Gustave Roussy

Villejuif, , France

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Agios Savvas Anticancer Hospital

Athens, , Greece

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251 General Airforce Hospital

Athens, , Greece

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General Hospital of Athens Laiko

Athens, , Greece

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Evgenidio Hospital I Agia Trias

Athens, , Greece

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Metropolitan Hospital

Athens, , Greece

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University Hospital of Heraklion

Heraklion - Crete, , Greece

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University Hospital of Larissa

Larissa, , Greece

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University Hospital of Patras

Pátrai, , Greece

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Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, , Greece

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Bioclinic of Thessaloniki

Thessaloniki, , Greece

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Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

Győr, , Hungary

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Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

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Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, , Hungary

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Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyíregyháza, , Hungary

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Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, , Hungary

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St James Hospital

Dublin, , Ireland

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St Vincents University Hospital

Dublin, , Ireland

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Assuta Medical Center

Jerusalem, , Israel

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Hadassah Ein-Kerem Medical Center

Jerusalem, , Israel

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Meir Medical Center

Kfar Saba, , Israel

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Istituto Ospedaliero Fondazione Poliambulanza

Brescia, , Italy

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Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

Catania, , Italy

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Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

Lecce, , Italy

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Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

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Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

Monserrato CA, , Italy

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Azienda Unita Saniataria Locale IRCCS di Reggio Emilia

Reggio Emilia, , Italy

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

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Azienda Ospedaliera San Giovanni Addolorata

Roma, , Italy

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IRCCS Istituto Clinico Humanitas

Rozzano MI, , Italy

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Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

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Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, , Italy

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Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia

Udine, , Italy

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Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento

Verona, , Italy

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Aichi Cancer Center

Nagoya, Aichi-ken, Japan

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Nagoya University Hospital

Nagoya, Aichi-ken, Japan

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Chiba Cancer Center

Chiba, Chiba, Japan

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National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

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National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

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National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

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Gifu University Hospital

Gifu, Gifu, Japan

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

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Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

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Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

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Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

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Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

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Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

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Kyoto University Hospital

Kyoto, Kyoto, Japan

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Niigata Cancer Center Hospital

Niigata, Niigata, Japan

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Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

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Osaka International Cancer Institute

Osaka, Osaka, Japan

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Kindai University Hospital

Osakasayama-shi, Osaka, Japan

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Osaka University Hospital

Suita-shi, Osaka, Japan

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Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

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Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

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The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

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Keio University Hospital

Shinjuku-ku, Tokyo, Japan

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Pauls Stradins Clinical University Hospital

Riga, , Latvia

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Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos

Kaunas, , Lithuania

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Viesoji istaiga Klaipedos universitetine ligonine

Klaipėda, , Lithuania

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Nacionalinis vezio institutas

Vilnius, , Lithuania

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Vilnius University Hospital Santaros Clinic Public Institution

Vilnius, , Lithuania

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Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

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University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

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Sarawak General Hospital

Kuching, Sarawak, Malaysia

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Centro Oncologico Internacional

Tijuana, Baja California Norte, Mexico

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Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

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Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

Zapopan, Jalisco, Mexico

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Christus Muguerza Clinica Vidriera

Monterrey, Nuevo León, Mexico

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Filios Alta Medicina sa de cv

Monterrey, Nuevo León, Mexico

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Investigación Biomédica para el Desarrollo de Fármacos

Aguascalientes, , Mexico

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Trials In Medicine SC

México, , Mexico

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Oslo University Hospital

Oslo, , Norway

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Centro de Investigacion Clinica Trujillo Eirl

Trujillo, La Libertad, Peru

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Instituto Peruano de Oncologia y Radioterapia

San Isidro, Lima region, Peru

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Centro Medico Monte Carmelo

Arequipa, , Peru

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Oncosalud

Lima, , Peru

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Centrum Onkologii im prof Franciszka Lukaszczyka

Bydgoszcz, , Poland

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Szpitale Pomorskie Spzoo

Gdynia, , Poland

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Biokinetica SA

Józefów, , Poland

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Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie

Koszalin, , Poland

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Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji

Olsztyn, , Poland

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SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu

Opole, , Poland

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Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie

Poznan, , Poland

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Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, , Poland

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Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal

Radom, , Poland

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Unidade Local de Saude de Coimbra, EPE

Coimbra, , Portugal

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Unidade Local de Saude do Alto Ave, EPE

Guimarães, , Portugal

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Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, , Portugal

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Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, , Portugal

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Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Site Status

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, , Portugal

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Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao

Santa Maria da Feira, , Portugal

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Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare

Baia Mare, , Romania

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Institutul Clinic Fundeni

Bucharest, , Romania

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Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti

Bucharest, , Romania

Site Status

SC Medisprof SRL

Cluj-Napoca, , Romania

Site Status

Institutul Regional de Oncologie Iasi

Iași, , Romania

Site Status

Ovidius Clinical Hospital

Ovidiu, , Romania

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

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The Oncology Centre

Durban, , South Africa

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Sandton Oncology Centre

Gauteng, , South Africa

Site Status

Netcare Milpark Hospital

Johannesburg, , South Africa

Site Status

Steve Biko Academic Hospital

Pretoria, , South Africa

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Site Status

The Catholic University of Korea Incheon St Marys Hospital

Incheon, , South Korea

Site Status

Jeonbuk National University Hospital

Jeonju-si, Jeollabuk-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Site Status

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Site Status

Hospital Donostia

Donostia / San Sebastian, Basque Country, Spain

Site Status

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, Catalonia, Spain

Site Status

Complexo Hospitalario Universitario de Ourense

Ourense, Galicia, Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status

Hospital General Universitario Jose Maria Morales Meseguer

Murcia, , Spain

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Karolinska Universitetssjukhuset Huddinge

Stockholm, , Sweden

Site Status

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan District, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, , Turkey (Türkiye)

Site Status

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Antalya Egitim ve Arastirma Hastanesi

Antalya, , Turkey (Türkiye)

Site Status

Dicle Universitesi Tip Fakultesi

Diyarbakır, , Turkey (Türkiye)

Site Status

Bezmialem Vakif Universitesi Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Site Status

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Kartal Dr Lutfi Kirdar Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Izmir Ataturk Egitim ve Arastirma Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, , Turkey (Türkiye)

Site Status

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, , Turkey (Türkiye)

Site Status

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, , Turkey (Türkiye)

Site Status

Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi

Van, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Belgium Brazil Bulgaria Canada Chile China Colombia Czechia Denmark Estonia France Greece Hungary Ireland Israel Italy Japan Latvia Lithuania Malaysia Mexico Norway Peru Poland Portugal Romania Singapore South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye)

References

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Rha SY, Zhang Y, Elme A, Pazo Cid R, Alacacioglu A, Ziogas DC, Shitara K, Ranceva A, Nemecek R, Santoro A, Calderon CA, Korphaisarn K, Davis T, Zahlten-Kuemeli A, Conn C, Tan M, Honeycutt H, Wainberg ZA. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO Precis Oncol. 2025 Jan;9:e2400710. doi: 10.1200/PO-24-00710. Epub 2025 Jan 24.

Reference Type BACKGROUND
PMID: 39854659 (View on PubMed)

Farooq AV, Kaur S, Hundal P, Burke M, Sulaiman R, Zahlten-Kumeli A, Raoof S, Li Z, Murias Dos Santos T, Huang XJ, Colby K. Advancing Ocular Safety Profile Assessment: A Novel Grading Scale for Ocular Adverse Reactions Associated with Bemarituzumab. Ophthalmol Ther. 2025 Jul;14(7):1349-1356. doi: 10.1007/s40123-025-01139-6. Epub 2025 May 12.

Reference Type BACKGROUND
PMID: 40355729 (View on PubMed)

Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.

Reference Type DERIVED
PMID: 38308771 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2023-505457-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

20210096

Identifier Type: -

Identifier Source: org_study_id

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