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

Gastric Cancer Clinical Trial

— FORTITUDE-101  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052801
• Other study ID #: 20210096
• Secondary ID: 2023-505457-40
• Status: Recruiting
• Phase: Phase 3
• Start date: March 7, 2022
• Est. completion date: August 18, 2025

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 516
• Est. completion date: August 18, 2025
• Est. primary completion date: August 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Bemarituzumab
Intravenous (IV) infusion
• 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.
• Placebo
IV infusion

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Zai Lab (China only)

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Progression-free Survival (PFS)	PFS in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Objective Response Rate (ORR)	ORR in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)	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
Secondary	Overall Survival	Overall survival in all randomized participants	Up to approximately 3.5 years
Secondary	Progression-free Survival (PFS)	PFS in all randomized participants	Up to approximately 3.5 years
Secondary	Objective Response Rate (ORR)	ORR in all randomized participants	Up to approximately 3.5 years
Secondary	Duration of Response (DOR)	DOR in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Disease Control Rate	Disease Control Rate in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
Secondary	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)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	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)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
Secondary	Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Baseline up to approximately 3.5 years
Secondary	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)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Up to approximately 3.5 years
Secondary	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)	Measured in FGFR2b = 10% 2+/3+ tumor cell staining participants	Day 1 up to approximately 3.5 years
Secondary	Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma		Day 1 up to approximately 3.5 years
Secondary	Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma		Day 1 up to approximately 3.5 years
Secondary	Number of Participants with an Anti-bemarituzumab Antibody Formation		Day 1 up to approximately 3.5 years

External Links

•   AmgenTrials clinical trials website