Clinical trial NCT05052801: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Keywords: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Bemarituzumab
FGFR2b Overexpression
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Zai Lab (China only)
First posted: 2021-09-22
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 3.5 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 3.5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3.5 years
measure: Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to approximately 3.5 years
measure: Overall Survival
timeFrame: Up to approximately 3.5 years
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 3.5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3.5 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 3.5 years
measure: Disease Control Rate
timeFrame: Up to approximately 3.5 years
measure: Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
timeFrame: Up to approximately 3.5 years
measure: Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
timeFrame: Baseline up to approximately 3.5 years
measure: Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
timeFrame: Up to approximately 3.5 years
measure: Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
timeFrame: Baseline up to approximately 3.5 years
measure: Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
timeFrame: Up to approximately 3.5 years
measure: Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
timeFrame: Baseline up to approximately 3.5 years
measure: Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)
timeFrame: Up to approximately 3.5 years
measure: Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
timeFrame: Up to approximately 3.5 years
measure: Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
timeFrame: Up to approximately 3.5 years
measure: Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
timeFrame: Day 1 up to approximately 3.5 years
measure: Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
timeFrame: Day 1 up to approximately 3.5 years
measure: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
timeFrame: Day 1 up to approximately 3.5 years
measure: Number of Participants with an Anti-bemarituzumab Antibody Formation
timeFrame: Day 1 up to approximately 3.5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Cerritos
country: United States
facility: The Oncology Institute Clinical Research
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Indianapolis
country: United States
facility: Saint Francis Medical Group
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Brooklyn
country: United States
facility: Healthier Hematology and Oncology Excelsior Integrated Medical Group
state: New York
city: White Plains
country: United States
facility: White Plains Hospital Center for Cancer Care
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute University
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Caba
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Universitario Fundacion Favaloro
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Sociedad de Beneficencia Hospital Italiano
state: Córdoba
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario de Cordoba
state: Córdoba
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Exelsus Oncologia Clinica
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento IADT
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
state: Bahia
city: Curitiba
country: Brazil
facility: Centro de Oncologia Mackenzie
state: Paraná
city: Ijui
country: Brazil
facility: Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clinica de Oncologia Reichow
state: Santa Catarina
city: Florianopolis
country: Brazil
facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: São Paulo
country: Brazil
facility: Hospital Nove de Julho - dasa
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer Ibcc
city: Branipole Village
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Park Hospital EOOD
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Pulmed OOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer
state: Cautín
city: Temuco
country: Chile
facility: Clinica CIDO
state: Cautín
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos SAGA Spa
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos e Investigaciones Medicas CeCim
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Wuwei
country: China
facility: Gansu Wuwei Tumour Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of science and Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital Affiliated Hospital of Hubei University of Medicine
state: Hubei
city: Wuhan City
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Wuhan
country: China
facility: The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: The Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Changzhi
country: China
facility: Changzhi Peoples Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliate Hospital of Ningbo University
state: Zhejiang
city: Quzhou
country: China
facility: Peoples Hospital of Quzhou
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer institute and hospital
city: Rionegro
country: Colombia
facility: Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia del Cesar
state: Cesar
city: Bucaramanga
country: Colombia
facility: Fundacion Cardiovascular de Colombia
state: Santander
city: Pasto
country: Colombia
facility: Instituto Cancerologico de Narino Ltda
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
city: Avignon cedex 9
country: France
facility: Sainte Catherine - Institut du Cancer d Avignon
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
city: Brest Cedex
country: France
facility: Centre Hospitalier Universitaire de Brest - Cavale Blanche
city: Clermont-Ferrand cedex 1
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
city: Lyon cedex 8
country: France
facility: Centre Leon Berard
city: Paris Cedex 14
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Reims Cedex
country: France
facility: Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
city: Strasbourg cedex
country: France
facility: Institut de cancerologie Strasbourg Europe
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Athens
country: Greece
facility: Agios Savvas Anticancer Hospital
city: Athens
country: Greece
facility: 251 General Airforce Hospital
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: Evgenidio Hospital I Agia Trias
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Heraklion - Crete
country: Greece
facility: University Hospital of Heraklion
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patra
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki Theageneio
city: Thessaloniki
country: Greece
facility: Bioclinic of Thessaloniki
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz
city: Dublin 4
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Jerusalem
country: Israel
facility: Assuta Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Brescia
country: Italy
facility: Istituto Ospedaliero Fondazione Poliambulanza
city: Catania
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
city: Lecce
country: Italy
facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Monserrato CA
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
city: Reggio Emilia
country: Italy
facility: Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
city: Rozzano MI
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Tricase
country: Italy
facility: Azienda Ospedaliera Cardinale Giovanni Panico
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St Marys Hospital
city: Jeonju-si, Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
city: Klaipeda
country: Lithuania
facility: Viesoji istaiga Klaipedos universitetine ligonine
city: Vilnius
country: Lithuania
facility: Nacionalinis vezio institutas
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinic Public Institution
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
city: Tijuana
country: Mexico
facility: Centro Oncologico Internacional
state: Baja California Norte
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
state: Jalisco
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera
state: Nuevo León
city: Monterrey
country: Mexico
facility: Filios Alta Medicina sa de cv
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos
city: Mexico
country: Mexico
facility: Trials In Medicine SC
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trujillo
country: Peru
facility: Centro de Investigacion Clinica Trujillo Eirl
state: La Libertad
city: San Isidro
country: Peru
facility: Instituto Peruano de Oncologia y Radioterapia
state: Lima
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Lima
country: Peru
facility: Oncosalud
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im prof Franciszka Lukaszczyka
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Spzoo
city: Jozefow
country: Poland
facility: Biokinetica SA
city: Koszalin
country: Poland
facility: Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
city: Olsztyn
country: Poland
facility: Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
city: Opole
country: Poland
facility: SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
city: Radom
country: Poland
facility: Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra, EPE
city: Guimaraes
country: Portugal
facility: Unidade Local de Saude do Alto Ave, EPE
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
city: Santa Maria da Feira
country: Portugal
facility: Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
city: Cluj-Napoca
country: Romania
facility: SC Medisprof SRL
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Durban
country: South Africa
facility: The Oncology Centre
city: Gauteng
country: South Africa
facility: Sandton Oncology Centre
city: Johannesburg
country: South Africa
facility: Netcare Milpark Hospital
city: Tshwane
country: South Africa
facility: Steve Biko Academic Hospital
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla León
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Galicia
city: San Sebastian
country: Spain
facility: Hospital Donostia
state: País Vasco
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Murcia
country: Spain
facility: Hospital General Universitario Jose Maria Morales Meseguer
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastirma Hastanesi
city: Diyarbakir
country: Turkey
facility: Dicle Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi
city: Izmir
country: Turkey
facility: Izmir Ataturk Egitim ve Arastirma Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi
city: Sakarya
country: Turkey
facility: Sakarya Egitim ve Arastirma Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Van
country: Turkey
facility: Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.