Esophageal Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive 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
Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

516

Study ID:

NCT05052801

Recruitment Status:

Recruiting

Sponsor:

Amgen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 181 Locations for this study

See Locations Near You

Alaska Oncology and Hematology LLC
Anchorage Alaska, 99508, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
University of California Los Angeles Bowyer Hematology-Oncology Clinic
Los Angeles California, 90095, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States
Saint Francis Medical Group
Indianapolis Indiana, 46237, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Healthier Hematology & Oncology Excelsior Integrated Medical Group
Brooklyn New York, 11220, United States
White Plains Hospital Medical Center
White Plains New York, 10604, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57108, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Instituto Alexander Fleming
Caba Buenos Aires, C1426, Argentina
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires Buenos Aires, C1093, Argentina
Sociedad de Beneficencia Hospital Italiano
Cordoba Córdoba, 5000, Argentina
Hospital Provincial del Centenario
Rosario Santa Fe, S2002, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucuman Tucuman, 4000, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires , C1122, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires , C1280, Argentina
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
St John of God Murdoch Hospital
Murdoch Western Australia, 6150, Australia
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege , 4000, Belgium
Nucleo de Oncologia da Bahia
Salvador Bahia, 40170, Brazil
Centro de Oncologia Mackenzie
Curitiba Paraná, 80440, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia LTDA
Ijui Rio Grande Do Sul, 98700, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Clinica de Oncologia Reichow
Blumenau Santa Catarina, 89010, Brazil
Cepon - Centro de Pesquisa Oncologicas
Florianopolis Santa Catarina, 88034, Brazil
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
Santo Andre São Paulo, 09060, Brazil
Instituto Nacional de Cancer INCA
Rio de Janeiro , 20231, Brazil
Hospital Nove de Julho - DASA
São Paulo , 01409, Brazil
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo , 04014, Brazil
Multiprofile Hospital for Active Treatment Park Hospital EOOD
Branipole Village , 4109, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo , 6300, Bulgaria
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Pleven , 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv , 4002, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia , 1407, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia , 1632, Bulgaria
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
James Lind Centro de Investigacion del Cancer
Temuco Cautín, 48008, Chile
Clinica CIDO
Temuco Cautín, 48102, Chile
Centro de Estudios Clinicos SAGA Spa
Santiago , 75006, Chile
Biocinetic SpA
Santiago , 83200, Chile
Clinica Somer Research Unit
Rionegro Antioquia, 05404, Colombia
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Fakultni Thomayerova nemocnice
Praha 4 , 140 5, Czechia
Rigshospitalet
Copenhagen , 2100, Denmark
North Estonia Medical Centre Foundation
Tallinn , 13419, Estonia
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besançon , 25030, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille Cedex , 59037, France
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
Saint Priest en Jarez , 42270, France
Institut Gustave Roussy
Villejuif , 94805, France
251 General Airforce Hospital
Athens , 11525, Greece
General Hospital of Athens Laiko
Athens , 11527, Greece
Evgenidio Hospital I Agia Trias
Athens , 11528, Greece
Metropolitan Hospital
Athens , 18547, Greece
University Hospital of Heraklion
Heraklion - Crete , 71500, Greece
University Hospital of Patras
Patra , 26504, Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki , 54007, Greece
Bioclinic of Thessaloniki
Thessaloniki , 54622, Greece
Petz Aladar Egyetemi Oktato Korhaz
Gyor , 9024, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula , 5700, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc , 3526, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszard , 7100, Hungary
Istituto Ospedaliero Fondazione Poliambulanza
Brescia , 25124, Italy
Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
Catania , 95122, Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce , 73100, Italy
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA , 09042, Italy
Azienda Unita Saniataria Locale IRCCS di Reggio Emilia
Reggio Emilia , 42100, Italy
Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma , 00184, Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI , 20089, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino , 10128, Italy
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase , 73039, Italy
Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia
Udine , 33100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Verona , 37126, Italy
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
Nagoya University Hospital
Nagoya-shi Aichi, 466-8, Japan
Chiba Cancer Center
Chiba-shi Chiba, 260-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi Ehime, 791-0, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan
Gifu University Hospital
Gifu-shi Gifu, 501-1, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
Hyogo Cancer Center
Akashi-shi Hyogo, 673-8, Japan
Kobe City Medical Center General Hospital
Kobe-shi Hyogo, 650-0, Japan
Ishikawa Prefectural Central Hospital
Kanazawa-shi Ishikawa, 920-8, Japan
Yokohama City University Medical Center
Yokohama-shi Kanagawa, 232-0, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi Kanagawa, 241-8, Japan
Niigata Cancer Center Hospital
Niigata-shi Niigata, 951-8, Japan
Kansai Medical University Hospital
Hirakata-shi Osaka, 573-1, Japan
Osaka International Cancer Institute
Osaka-shi Osaka, 541-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Osaka University Hospital
Suita-shi Osaka, 565-0, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
Jeonbuk National University Hospital
Jeonju-si, Jeollabuk-do , 54907, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
Seoul , 06591, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Pauls Stradins Clinical University Hospital
Riga , 1002, Latvia
Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos
Kaunas , 50161, Lithuania
Viesoji istaiga Klaipedos universitetine ligonine
Klaipeda , 92288, Lithuania
Nacionalinis vezio institutas
Vilnius , 08660, Lithuania
Vilnius University Hospital Santaros Clinic Public Institution
Vilnius , 08661, Lithuania
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara Jalisco, 44280, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan Jalisco, 45070, Mexico
Christus Muguerza Clinica Vidriera
Monterrey Nuevo León, 64570, Mexico
Investigación Biomédica para el Desarrollo de Fármacos SA de CV
Aguascalientes , 20010, Mexico
Trials In Medicine SC
Mexico , 06720, Mexico
Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz , 85-79, Poland
Szpitale Pomorskie Spzoo
Gdynia , 81-51, Poland
Biokinetica SA
Jozefow , 05-41, Poland
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
Opole , 45-06, Poland
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
Poznan , 61-86, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemysl , 37-70, Poland
Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal
Radom , 26-60, Poland
Centro Hospitalar e Universitario de Coimbra EPE
Coimbra , 3004-, Portugal
Hospital da Senhora da Oliveira Guimaraes, EPE
Guimaraes , 4835-, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa , 1649-, Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto , 4099-, Portugal
Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao Sebastiao
Santa Maria da Feira , 4520-, Portugal
Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia Mare
Baia Mare , 43003, Romania
Institutul Clinic Fundeni
Bucharest , 02232, Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucuresti , 02233, Romania
SC Medisprof SRL
Cluj-Napoca , 40005, Romania
Institutul Regional de Oncologie Iasi
Iasi , 70048, Romania
Ovidius Clinical Hospital
Ovidiu , 90590, Romania
National Cancer Centre Singapore
Singapore , 16961, Singapore
Hospital Universitario Reina Sofia
Cordoba Andalucía, 14004, Spain
Hospital Regional Universitario de Malaga
Malaga Andalucía, 29010, Spain
Hospital Universitario Miguel Servet
Zaragoza Aragón, 50009, Spain
Hospital Universitario de Burgos
Burgos Castilla León, 09006, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Cataluña, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona Cataluña, 08041, Spain
Corporacio Sanitaria Parc Tauli
Sabadell Cataluña, 08208, Spain
Hospital Universitari i Politecnic La Fe
Valencia Comunidad Valenciana, 46026, Spain
Complexo Hospitalario Universitario de Ourense
Ourense Galicia, 32005, Spain
Hospital Donostia
San Sebastian País Vasco, 20014, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28009, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid , 28220, Spain
Hospital General Universitario Jose Maria Morales Meseguer
Murcia , 30008, Spain
Sahlgrenska Universitetssjukhuset
Göteborg , 413 4, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm , 141 8, Sweden
Norrlands Universitetssjukhus
Umea , 901 8, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok , 10330, Thailand
Rajavithi Hospital
Bangkok , 10400, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana , 01250, Turkey
Hacettepe Universitesi Tip Fakultesi
Ankara , 06230, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Ankara Sehir Hastanesi
Ankara , 06800, Turkey
Dicle Universitesi Tip Fakultesi
Diyarbakir , 21080, Turkey
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul , 34093, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul , 34098, Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul , 34722, Turkey
Izmir Ataturk Egitim ve Arastirma Hastanesi
Izmir , 35150, Turkey
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
Kocaeli , 41380, Turkey
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Sakarya , 54290, Turkey
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
Samsun , 55200, Turkey
Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi
Van , 65000, Turkey

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

516

Study ID:

NCT05052801

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.