Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101)

April 10, 2024 updated by: Amgen

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

516

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amgen Call Center
Phone Number: 866-572-6436
Email: medinfo@amgen.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1122AAL
    - Recruiting
    - Instituto Argentino de Diagnostico y Tratamiento IADT
  - Buenos Aires, Argentina, C1280AEB
    - Recruiting
    - Hospital Britanico de Buenos Aires
- Buenos Aires
  - Caba, Buenos Aires, Argentina, C1426ANZ
    - Recruiting
    - Instituto Alexander Fleming
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
    - Recruiting
    - Hospital Universitario Fundación Favaloro
- Córdoba
  - Cordoba, Córdoba, Argentina, 5000
    - Recruiting
    - Sociedad de Beneficencia Hospital Italiano
  - Cordoba, Córdoba, Argentina, X5016KEH
    - Recruiting
    - Hospital Privado Universitario de Córdoba
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2002KDS
    - Recruiting
    - Hospital Provincial del Centenario
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, 4000
    - Recruiting
    - Exelsus Oncologia Clinica
Australia
- New South Wales
  - Liverpool, New South Wales, Australia, 2170
    - Recruiting
    - Liverpool Hospital
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Recruiting
    - St John of God Murdoch Hospital
Belgium
- - Edegem, Belgium, 2650
    - Recruiting
    - Universitair Ziekenhuis Antwerpen
  - Gent, Belgium, 9000
    - Recruiting
    - Universitair Ziekenhuis Gent
  - Leuven, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  - Liege, Belgium, 4000
    - Recruiting
    - Centre Hospitalier Universitaire de Liege - Sart Tilman
Brazil
- - Rio de Janeiro, Brazil, 20231-050
    - Recruiting
    - Instituto Nacional de Cancer
  - São Paulo, Brazil, 01409-001
    - Recruiting
    - Hospital Nove de Julho - dasa
  - São Paulo, Brazil, 04014-002
    - Recruiting
    - Instituto Brasileiro de Controle do Cancer Ibcc
- Bahia
  - Salvador, Bahia, Brazil, 40170-110
    - Recruiting
    - Nucleo de Oncologia da Bahia
- Paraná
  - Curitiba, Paraná, Brazil, 80440-220
    - Recruiting
    - Centro de Oncologia Mackenzie
- Rio Grande Do Sul
  - Ijui, Rio Grande Do Sul, Brazil, 98700-000
    - Recruiting
    - Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Recruiting
    - Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89010-340
    - Recruiting
    - Clinica de Oncologia Reichow
  - Florianopolis, Santa Catarina, Brazil, 88020-210
    - Recruiting
    - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
- São Paulo
  - Santo Andre, São Paulo, Brazil, 09060-650
    - Recruiting
    - Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
Bulgaria
- - Branipole Village, Bulgaria, 4109
    - Recruiting
    - Multiprofile Hospital for Active Treatment Park Hospital EOOD
  - Haskovo, Bulgaria, 6300
    - Recruiting
    - Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
  - Pleven, Bulgaria, 5800
    - Terminated
    - University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
  - Plovdiv, Bulgaria, 4002
    - Recruiting
    - University Multiprofile Hospital for Active Treatment Pulmed OOD
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
  - Sofia, Bulgaria, 1632
    - Recruiting
    - Multiprofile Hospital for Active Treatment Serdika EOOD
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Cross Cancer Institute
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - The Ottawa Hospital Cancer Centre
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Sunnybrook Research Institute Sunnybrook Health Sciences Centre
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Jewish General Hospital
Chile
- - Santiago, Chile, 7500653
    - Recruiting
    - Centro de Estudios Clínicos SAGA SpA
  - Santiago, Chile, 8320000
    - Recruiting
    - Centro de Estudios Clinicos e Investigaciones Medicas CeCim
- Cautín
  - Temuco, Cautín, Chile, 4800827
    - Recruiting
    - James Lind Centro de Investigacion del Cancer
  - Temuco, Cautín, Chile, 4810218
    - Recruiting
    - Clinica CIDO
China
- - Beijing, China, 100142
    - Recruiting
    - Beijing Cancer Hospital
  - Tianjin, China, 300060
    - Recruiting
    - Tianjin Medical University Cancer Institute and Hospital
- Anhui
  - Bengbu, Anhui, China, 233099
    - Recruiting
    - the First Affiliated Hospital of Bengbu Medical College
  - Hefei, Anhui, China, 230022
    - Recruiting
    - The First Affiliated Hospital of Anhui Medical University
  - Hefei, Anhui, China, 230031
    - Recruiting
    - Anhui Provincial Cancer Hospital
- Beijing
  - Beijing, Beijing, China, 100021
    - Recruiting
    - Cancer Hospital of Chinese Academy of Medical Sciences
  - Beijing, Beijing, China, 100032
    - Recruiting
    - Huntington Medical Education Foundation
- Chongqing
  - Chongqing, Chongqing, China, 400037
    - Recruiting
    - Chongqing University Three Gorges Hospital
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Recruiting
    - Fujian Medical University Union Hospital
  - Fuzhou, Fujian, China, 350014
    - Recruiting
    - Fujian Cancer Hospital
  - Xiamen, Fujian, China, 361003
    - Recruiting
    - The First Affiliated Hospital of Xiamen University
- Gansu
  - Lanzhou, Gansu, China, 730030
    - Recruiting
    - Lanzhou University Second Hospital
  - Wuwei, Gansu, China, 733000
    - Recruiting
    - Gansu Wuwei Tumour Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510700
    - Recruiting
    - Sun Yat-sen University Cancer Center
  - Guangzhou, Guangdong, China, 510030
    - Recruiting
    - Sun Yat-sen University Cancer Center
  - Guangzhou, Guangdong, China, 510180
    - Recruiting
    - Guangdong Provincial Peoples Hospital
  - Shantou, Guangdong, China, 515031
    - Recruiting
    - Cancer Hospital of Shantou University Medical College
- Hainan
  - Haikou, Hainan, China, 570102
    - Recruiting
    - The First Affiliated Hospital of Hainan Medical University
- Hebei
  - Shijiazhuang, Hebei, China, 050011
    - Recruiting
    - Fourth Hospital of Hebei Medical University
  - Wuhan, Hebei, China, 430030
    - Recruiting
    - Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
- Heilongjiang
  - Harbin, Heilongjiang, China, 150000
    - Recruiting
    - Harbin Medical University Cancer Hospital
- Henan
  - Anyang, Henan, China, 455001
    - Recruiting
    - Anyang Cancer Hospital
  - Luoyang, Henan, China, 471000
    - Recruiting
    - The First Affiliated Hospital of Henan University of Science and Technology
  - Zhengzhou, Henan, China, 450000
    - Recruiting
    - Henan Cancer Hospital
  - Zhengzhou, Henan, China, 450052
    - Recruiting
    - The First Affiliated Hospital of Zhengzhou University
- Hubei
  - Shiyan, Hubei, China, 442000
    - Recruiting
    - Taihe Hospital Affiliated Hospital of Hubei University of Medicine
  - Wuhan, Hubei, China, 430000
    - Recruiting
    - The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
  - Wuhan City, Hubei, China, 430079
    - Recruiting
    - Hubei Cancer Hospital
- Hunan
  - Changsha, Hunan, China, 410006
    - Recruiting
    - Hunan Cancer Hospital
  - Changsha, Hunan, China, 410000
    - Recruiting
    - Xiangya Hospital of Central South University
- Jiangsu
  - Nanjing, Jiangsu, China, 210006
    - Recruiting
    - Nanjing First Hospital
  - Suzhou, Jiangsu, China, 215004
    - Recruiting
    - The Second Affiliated Hospital of Soochow University
  - Wuxi, Jiangsu, China, 214122
    - Recruiting
    - Affiliated Hospital of Jiangnan University
  - Xuzhou, Jiangsu, China, 221002
    - Recruiting
    - The Affiliated Hospital Of Xuzhou Medical University
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University
- Jilin
  - Changchun, Jilin, China, 130021
    - Recruiting
    - The First Hospital of Jilin University
  - Changchun, Jilin, China, 130022
    - Recruiting
    - China-Japan Union Hospital of Jilin University
- Liaoning
  - Jinzhou, Liaoning, China, 121000
    - Recruiting
    - The First Affiliated Hospital Of Jinzhou Medical University
  - Shenyang, Liaoning, China, 110001
    - Recruiting
    - The First Hospital of China Medical University
  - Shenyang, Liaoning, China, 110042
    - Recruiting
    - Liaoning Cancer Hospital
- Shaanxi
  - XI An, Shaanxi, China, 710061
    - Recruiting
    - The First Affiliated Hospital of Xi An Jiaotong University
- Shandong
  - Jinan, Shandong, China, 250013
    - Recruiting
    - Jinan Central Hospital
  - Jinan, Shandong, China, 250117
    - Recruiting
    - The Affiliated Cancer Hospital of Shandong First Medical University
  - Qingdao, Shandong, China, 266000
    - Recruiting
    - The Affiliated Hospital Of Qingdao University
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Recruiting
    - Fudan University Shanghai Cancer Center
  - Shanghai, Shanghai, China, 200080
    - Recruiting
    - Shanghai General Hospital
  - Shanghai, Shanghai, China, 200032
    - Recruiting
    - Zhongshan Hospital Fudan University
  - Shanghai, Shanghai, China, 200123
    - Recruiting
    - Shanghai East Hospital
  - Shanghai, Shanghai, China, 201800
    - Recruiting
    - Ruijin Hospital Shanghai Jiao Tong University School of Medicine
- Shanxi
  - Changzhi, Shanxi, China, 046000
    - Recruiting
    - Changzhi Peoples Hospital
  - Linfen, Shanxi, China, 100032
    - Recruiting
    - Linfen Central Hospital
  - Taiyuan, Shanxi, China, 030013
    - Recruiting
    - Shanxi Province Cancer Hospital
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - Sichuan Cancer Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - Recruiting
    - The Second Affiliated Hospital Zhejiang University School of Medicine
  - Hangzhou, Zhejiang, China, 310016
    - Recruiting
    - Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital Zhejiang University School of Medicine
  - Linhai, Zhejiang, China, 317000
    - Recruiting
    - Taizhou Hospital of Zhejiang Province
  - Lishui, Zhejiang, China, 323000
    - Recruiting
    - Lishui Municipal Central Hospital
  - Ningbo, Zhejiang, China, 315010
    - Recruiting
    - The First Affiliate Hospital of Ningbo University
  - Quzhou, Zhejiang, China, 324000
    - Recruiting
    - Peoples Hospital of Quzhou
Colombia
- - Pasto, Colombia, 520002
    - Recruiting
    - Instituto Cancerologico de Narino Ltda
- Antioquia
  - Rionegro, Antioquia, Colombia, 054040
    - Recruiting
    - Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
- Cesar
  - Valledupar, Cesar, Colombia, 200001
    - Recruiting
    - Sociedad de Oncologia y Hematologia del Cesar
- Santander
  - Bucaramanga, Santander, Colombia, 681017
    - Recruiting
    - Fundacion Cardiovascular de Colombia
Czechia
- - Brno, Czechia, 656 53
    - Recruiting
    - Masarykuv onkologicky ustav
  - Hradec Kralove, Czechia, 500 05
    - Recruiting
    - Fakultni nemocnice Hradec Kralove
  - Olomouc, Czechia, 779 00
    - Recruiting
    - Fakultni nemocnice Olomouc
  - Praha 2, Czechia, 128 08
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze
  - Praha 4, Czechia, 140 59
    - Recruiting
    - Fakultni Thomayerova nemocnice
Denmark
- - Copenhagen, Denmark, 2100
    - Recruiting
    - Rigshospitalet
Estonia
- - Tallinn, Estonia, 13419
    - Recruiting
    - North Estonia Medical Centre Foundation
France
- - Amiens Cedex 1, France, 80054
    - Recruiting
    - Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
  - Avignon cedex 9, France, 84918
    - Recruiting
    - Sainte Catherine - Institut du Cancer d Avignon
  - Besançon, France, 25030
    - Recruiting
    - Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
  - Brest, France, 29200
    - Recruiting
    - Centre Hospitalier Universitaire de Brest - Cavale Blanche
  - Clermont-Ferrand cedex 1, France, 63003
    - Recruiting
    - Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
  - Lille, France, 59037
    - Recruiting
    - Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  - Lyon cedex 8, France, 69373
    - Recruiting
    - Centre Léon Bérard
  - Paris, France, 75015
    - Recruiting
    - Hôpital Européen Georges Pompidou
  - Paris Cedex 14, France, 75674
    - Recruiting
    - Institut Mutualiste Montsouris
  - Reims Cedex, France, 51092
    - Recruiting
    - Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
  - Saint Priest en Jarez, France, 42270
    - Recruiting
    - Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
  - Strasbourg cedex, France, 67065
    - Recruiting
    - Institut de cancérologie Strasbourg Europe
  - Villejuif, France, 94805
    - Recruiting
    - Institut Gustave Roussy
Greece
- - Athens, Greece, 18547
    - Recruiting
    - Metropolitan Hospital
  - Athens, Greece, 11528
    - Recruiting
    - Evgenidio Hospital I Agia Trias
  - Athens, Greece, 11525
    - Recruiting
    - 251 General Airforce Hospital
  - Athens, Greece, 11522
    - Recruiting
    - Agios Savvas Anticancer Hospital
  - Athens, Greece, 11526
    - Recruiting
    - General Hospital of Athens Laiko
  - Heraklion - Crete, Greece, 71500
    - Recruiting
    - University Hospital of Heraklion
  - Larissa, Greece, 41110
    - Recruiting
    - University Hospital Of Larissa
  - Patra, Greece, 26504
    - Recruiting
    - University Hospital of Patras
  - Thessaloniki, Greece, 54007
    - Recruiting
    - Anticancer Hospital of Thessaloniki Theageneio
  - Thessaloniki, Greece, 54622
    - Recruiting
    - Bioclinic of Thessaloniki
Hungary
- - Gyor, Hungary, 9024
    - Recruiting
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
  - Gyula, Hungary, 5700
    - Recruiting
    - Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  - Miskolc, Hungary, 3526
    - Recruiting
    - Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  - Nyiregyhaza, Hungary, 4400
    - Recruiting
    - Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
  - Szekszard, Hungary, 7100
    - Recruiting
    - Tolna Varmegyei Balassa Janos Korhaz
Ireland
- - Dublin, Ireland, 8
    - Recruiting
    - St James Hospital
  - Dublin 4, Ireland, D04T6F4
    - Recruiting
    - St Vincents University Hospital
Israel
- - Jerusalem, Israel, 9112001
    - Recruiting
    - Hadassah Ein-Kerem Medical Center
  - Jerusalem, Israel, 9103102
    - Recruiting
    - Assuta Medical Center
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Meir Medical Center
Italy
- - Brescia, Italy, 25124
    - Recruiting
    - Istituto Ospedaliero Fondazione Poliambulanza
  - Catania, Italy, 95122
    - Recruiting
    - Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
  - Lecce, Italy, 73100
    - Recruiting
    - Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
  - Milano, Italy, 20162
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  - Monserrato CA, Italy, 09042
    - Recruiting
    - Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
  - Reggio Emilia, Italy, 42100
    - Recruiting
    - Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
  - Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, Italy, 00184
    - Recruiting
    - Azienda Ospedaliera San Giovanni Addolorata
  - Rozzano MI, Italy, 20089
    - Recruiting
    - IRCCS Istituto Clinico Humanitas
  - Torino, Italy, 10128
    - Recruiting
    - Azienda Ospedaliera Ordine Mauriziano di Torino
  - Tricase, Italy, 73039
    - Recruiting
    - Azienda Ospedaliera Cardinale Giovanni Panico
  - Udine, Italy, 33100
    - Recruiting
    - Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
  - Verona, Italy, 37126
    - Recruiting
    - Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 464-8681
    - Recruiting
    - Aichi Cancer Center
  - Nagoya-shi, Aichi, Japan, 466-8560
    - Recruiting
    - Nagoya University Hospital
- Chiba
  - Chiba-shi, Chiba, Japan, 260-8717
    - Recruiting
    - Chiba Cancer Center
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama-shi, Ehime, Japan, 791-0280
    - Recruiting
    - National Hospital Organization Shikoku Cancer Center
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center
- Gifu
  - Gifu-shi, Gifu, Japan, 501-1194
    - Recruiting
    - Gifu University Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
- Hyogo
  - Akashi-shi, Hyogo, Japan, 673-8558
    - Recruiting
    - Hyogo Cancer Center
  - Kobe-shi, Hyogo, Japan, 650-0047
    - Recruiting
    - Kobe City Medical Center General Hospital
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan, 920-8530
    - Recruiting
    - Ishikawa Prefectural Central Hospital
- Kagawa
  - Kita-gun, Kagawa, Japan, 761-0793
    - Recruiting
    - Kagawa University Hospital
- Kanagawa
  - Yokohama-shi, Kanagawa, Japan, 232-0024
    - Recruiting
    - Yokohama City University Medical Center
  - Yokohama-shi, Kanagawa, Japan, 241-8515
    - Recruiting
    - Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
- Kyoto
  - Kyoto-shi, Kyoto, Japan, 606-8507
    - Recruiting
    - Kyoto University Hospital
- Niigata
  - Niigata-shi, Niigata, Japan, 951-8566
    - Recruiting
    - Niigata Cancer Center Hospital
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital
  - Osaka-shi, Osaka, Japan, 541-8567
    - Recruiting
    - Osaka International Cancer Institute
  - Osakasayama-shi, Osaka, Japan, 589-8511
    - Recruiting
    - Kindai University Hospital
  - Suita-shi, Osaka, Japan, 565-0871
    - Recruiting
    - Osaka University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Recruiting
    - Saitama Cancer Center
- Shizuoka
  - Sunto-gun, Shizuoka, Japan, 411-8777
    - Recruiting
    - Shizuoka Cancer Center
- Tokyo
  - Koto-ku, Tokyo, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Recruiting
    - Keio University Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 49201
    - Recruiting
    - Dong-A University Hospital
  - Daegu, Korea, Republic of, 41404
    - Recruiting
    - Kyungpook National University Chilgok Hospital
  - Daejeon, Korea, Republic of, 35015
    - Recruiting
    - Chungnam national university hospital
  - Goyang-si Gyeonggi-do, Korea, Republic of, 10408
    - Recruiting
    - National Cancer Center
  - Incheon, Korea, Republic of, 21431
    - Recruiting
    - The Catholic University of Korea Incheon St Marys Hospital
  - Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
    - Terminated
    - Jeonbuk National University Hospital
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 08308
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 03181
    - Recruiting
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Severance Hospital Yonsei University Health System
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - The Catholic University of Korea Seoul St Marys Hospital
Latvia
- - Riga, Latvia, 1002
    - Recruiting
    - Pauls Stradins Clinical University Hospital
Lithuania
- - Kaunas, Lithuania, 50161
    - Recruiting
    - Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
  - Klaipeda, Lithuania, 92288
    - Recruiting
    - Viesoji istaiga Klaipedos universitetine ligonine
  - Vilnius, Lithuania, 08660
    - Recruiting
    - Nacionalinis vezio institutas
  - Vilnius, Lithuania, 08661
    - Recruiting
    - Vilnius University Hospital Santaros Clinic Public Institution
Malaysia
- Sarawak
  - Kuching, Sarawak, Malaysia, 93586
    - Recruiting
    - Sarawak General Hospital
- Wilayah Persekutuan
  - Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
    - Recruiting
    - University Malaya Medical Centre
  - Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
    - Recruiting
    - Hospital Kuala Lumpur
Mexico
- - Aguascalientes, Mexico, 20010
    - Recruiting
    - Investigación Biomédica para el Desarrollo de Fármacos
  - Mexico, Mexico, 06720
    - Recruiting
    - Trials In Medicine SC
- Baja California Norte
  - Tijuana, Baja California Norte, Mexico, 22010
    - Recruiting
    - Centro Oncologico Internacional
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Recruiting
    - Hospital Civil de Guadalajara Fray Antonio Alcalde
  - Zapopan, Jalisco, Mexico, 45070
    - Recruiting
    - Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64570
    - Terminated
    - Christus Muguerza Clinica Vidriera
  - Monterrey, Nuevo León, Mexico, 64570
    - Recruiting
    - Filios Alta Medicina sa de cv
Norway
- - Oslo, Norway, 0424
    - Recruiting
    - Oslo University Hospital
Peru
- La Libertad
  - Trujillo, La Libertad, Peru, 13001
    - Recruiting
    - Centro de Investigacion Clinica Trujillo Eirl
Poland
- - Bydgoszcz, Poland, 85-796
    - Recruiting
    - Centrum Onkologii im prof Franciszka Lukaszczyka
  - Gdynia, Poland, 81-519
    - Recruiting
    - Szpitale Pomorskie Spzoo
  - Jozefow, Poland, 05-410
    - Recruiting
    - Biokinetica SA
  - Koszalin, Poland, 75-581
    - Recruiting
    - Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
  - Olsztyn, Poland, 10-228
    - Recruiting
    - Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
  - Opole, Poland, 45-060
    - Recruiting
    - SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
  - Poznan, Poland, 61-866
    - Recruiting
    - Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
  - Przemysl, Poland, 37-700
    - Recruiting
    - Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
  - Radom, Poland, 26-600
    - Recruiting
    - Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
Portugal
- - Coimbra, Portugal, 3004-561
    - Recruiting
    - Centro Hospitalar E Universitário de Coimbra EPE
  - Guimaraes, Portugal, 4835-044
    - Recruiting
    - Hospital da Senhora da Oliveira Guimaraes, EPE
  - Lisboa, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  - Porto, Portugal, 4200-072
    - Recruiting
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  - Porto, Portugal, 4200-319
    - Terminated
    - Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
  - Santa Maria da Feira, Portugal, 4520-211
    - Recruiting
    - Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao Sebastiao
Romania
- - Baia Mare, Romania, 430031
    - Recruiting
    - Spitalul Judeţean de Urgenţă Dr Constantin Opriş Baia Mare
  - Bucharest, Romania, 022328
    - Recruiting
    - Institutul Clinic Fundeni
  - Bucuresti, Romania, 022338
    - Recruiting
    - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
  - Cluj-Napoca, Romania, 400058
    - Recruiting
    - SC Medisprof SRL
  - Iasi, Romania, 700483
    - Recruiting
    - Institutul Regional de Oncologie Iasi
  - Ovidiu, Romania, 905900
    - Recruiting
    - Ovidius Clinical Hospital
Singapore
- - Singapore, Singapore, 168583
    - Recruiting
    - National Cancer Centre Singapore
South Africa
- - Durban, South Africa, 4001
    - Recruiting
    - The Oncology Centre
  - Gauteng, South Africa, 2021
    - Recruiting
    - Sandton Oncology Centre
  - Johannesburg, South Africa, 2196
    - Recruiting
    - Netcare Milpark Hospital
Spain
- - Madrid, Spain, 28009
    - Recruiting
    - Hospital General Universitario Gregorio Marañón
  - Madrid, Spain, 28220
    - Recruiting
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Murcia, Spain, 30008
    - Recruiting
    - Hospital General Universitario Jose Maria Morales Meseguer
- Andalucía
  - Cordoba, Andalucía, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofía
  - Malaga, Andalucía, Spain, 29010
    - Recruiting
    - Hospital Regional Universitario de Malaga
- Aragón
  - Zaragoza, Aragón, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet
- Castilla León
  - Burgos, Castilla León, Spain, 09006
    - Recruiting
    - Hospital Universitario de Burgos
- Cataluña
  - Barcelona, Cataluña, Spain, 08041
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Cataluña, Spain, 08036
    - Recruiting
    - Hospital Clinic i Provincial de Barcelona
  - Sabadell, Cataluña, Spain, 08208
    - Recruiting
    - Corporació Sanitària Parc Taulí
- Comunidad Valenciana
  - Valencia, Comunidad Valenciana, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe
- Galicia
  - Ourense, Galicia, Spain, 32005
    - Recruiting
    - Complexo Hospitalario Universitario de Ourense
- País Vasco
  - San Sebastian, País Vasco, Spain, 20014
    - Recruiting
    - Hospital Donostia
Sweden
- - Göteborg, Sweden, 413 45
    - Recruiting
    - Sahlgrenska Universitetssjukhuset
  - Stockholm, Sweden, 141 86
    - Recruiting
    - Karolinska Universitetssjukhuset Huddinge
  - Umea, Sweden, 901 85
    - Recruiting
    - Norrlands universitetssjukhus
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital
  - Kaohsiung, Taiwan, 80756
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital
  - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 11490
    - Recruiting
    - Tri-Service General Hospital
  - Taoyuan, Taiwan, 33305
    - Recruiting
    - Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Thailand
- - Bangkok, Thailand, 10700
    - Recruiting
    - Siriraj Hospital
  - Bangkok, Thailand, 10330
    - Recruiting
    - King Chulalongkorn Memorial Hospital
  - Bangkok, Thailand, 10400
    - Recruiting
    - Ramathibodi Hospital
  - Bangkok, Thailand, 10400
    - Recruiting
    - Rajavithi Hospital
Turkey
- - Adana, Turkey, 01250
    - Recruiting
    - Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
  - Ankara, Turkey, 06520
    - Recruiting
    - Memorial Ankara Hastanesi
  - Ankara, Turkey, 06100
    - Recruiting
    - Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  - Ankara, Turkey, 06800
    - Recruiting
    - Ankara Bilkent Sehir Hastanesi
  - Ankara, Turkey, 06230
    - Recruiting
    - Hacettepe Universitesi Tip Fakultesi Hastanesi
  - Antalya, Turkey, 07100
    - Recruiting
    - Antalya Egitim ve Arastirma Hastanesi
  - Diyarbakir, Turkey, 21080
    - Recruiting
    - Dicle Universitesi Tip Fakultesi
  - Istanbul, Turkey, 34098
    - Recruiting
    - Istanbul Universitesi Cerrahpasa Tip Fakultesi
  - Istanbul, Turkey, 34722
    - Recruiting
    - Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  - Istanbul, Turkey, 34865
    - Recruiting
    - Kartal Dr Lutfi Kirdar Sehir Hastanesi
  - Istanbul, Turkey, 34093
    - Recruiting
    - Bezmialem Vakif Universitesi Hastanesi
  - Izmir, Turkey, 35150
    - Recruiting
    - Izmir Ataturk Egitim ve Arastirma Hastanesi
  - Kocaeli, Turkey, 41380
    - Recruiting
    - Kocaeli Universitesi Tip Fakultesi Hastanesi
  - Malatya, Turkey, 44280
    - Recruiting
    - Inonu Universitesi Turgut Ozal Tip Merkezi
  - Sakarya, Turkey, 54290
    - Recruiting
    - Sakarya Egitim ve Arastirma Hastanesi
  - Samsun, Turkey, 55200
    - Recruiting
    - Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  - Van, Turkey, 65000
    - Completed
    - Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
United States
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Recruiting
    - Alaska Oncology and Hematology
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic Arizona
- California
  - Cerritos, California, United States, 90703
    - Recruiting
    - The Oncology Institute Clinical Research
  - Los Angeles, California, United States, 90095
    - Recruiting
    - University of California Los Angeles
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Florida
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Recruiting
    - Saint Francis Medical Group
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Completed
    - University of Michigan
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic Rochester
- New York
  - Brooklyn, New York, United States, 11220
    - Recruiting
    - Healthier Hematology and Oncology Excelsior Integrated Medical Group
  - White Plains, New York, United States, 10604
    - Recruiting
    - White Plains Hospital Medical Center
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Levine Cancer Institute University
  - Pinehurst, North Carolina, United States, 28374
    - Recruiting
    - FirstHealth Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57108
    - Recruiting
    - Avera Cancer Institute
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Inova Schar Cancer Institute
- Washington
  - Spokane, Washington, United States, 99208
    - Recruiting
    - Medical Oncology Associates, PS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bemarituzumab with mFOLFOX6	Drug: Bemarituzumab Intravenous (IV) infusion 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.
Active Comparator: Placebo with mFOLFOX6	Drug: Placebo IV infusion 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: Up to approximately 3.5 years	Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: Up to approximately 3.5 years	Overall survival in all randomized participants	Up to approximately 3.5 years
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma Time Frame: Day 1 up to approximately 3.5 years		Day 1 up to approximately 3.5 years
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma Time Frame: Day 1 up to approximately 3.5 years		Day 1 up to approximately 3.5 years
Number of Participants with an Anti-bemarituzumab Antibody Formation Time Frame: Day 1 up to approximately 3.5 years		Day 1 up to approximately 3.5 years
Progression-free Survival (PFS) Time Frame: Up to approximately 3.5 years	PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Objective Response Rate (ORR) Time Frame: Up to approximately 3.5 years	ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) Time Frame: Up to approximately 3.5 years	Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.	Up to approximately 3.5 years
Progression-free Survival (PFS) Time Frame: Up to approximately 3.5 years	PFS in all randomized participants	Up to approximately 3.5 years
Objective Response Rate (ORR) Time Frame: Up to approximately 3.5 years	ORR in all randomized participants	Up to approximately 3.5 years
Duration of Response (DOR) Time Frame: Up to approximately 3.5 years	DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Disease Control Rate Time Frame: Up to approximately 3.5 years	Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Time Frame: Baseline up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
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) Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
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) Time Frame: Baseline up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Time Frame: Baseline up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
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) Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score Time Frame: Up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
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) Time Frame: Day 1 up to approximately 3.5 years	Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants	Day 1 up to approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Zai Lab (China only)

Investigators

Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

AmgenTrials clinical trials website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

August 18, 2025

Study Completion (Estimated)

August 18, 2025

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

20210096
2023-505457-40 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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China
GlaxoSmithKline

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Infections, Bacterial

United States
Italfarmaco

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Becker Muscular Dystrophy

Netherlands, Italy
West Penn Allegheny Health System

Completed

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Asthma | Allergic Rhinitis

United States

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101)

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 Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Placebo

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