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).
Eligibility Criteria
Inclusion Criteria:
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
absolute neutrophil count greater than or equal to 1.5 times 10^9/L
platelet count greater than or equal to 100 times 10^9/L
hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Exclusion Criteria:
Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
Known human epidermal growth factor receptor 2 (HER2) positive
Untreated or symptomatic central nervous system (CNS) disease or brain metastases
Peripheral sensory neuropathy greater than or equal to Grade 2
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmological disorders
Major surgery or other investigational study within 28 days prior to first dose of study treatment
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
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There are 243 Locations for this study
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85054, United States
Cerritos California, 90703, United States
Los Angeles California, 90095, United States
Jacksonville Florida, 32224, United States
Indianapolis Indiana, 46237, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Brooklyn New York, 11220, United States
White Plains New York, 10604, United States
Charlotte North Carolina, 28204, United States
Pinehurst North Carolina, 28374, United States
Sioux Falls South Dakota, 57108, United States
Nashville Tennessee, 37232, United States
Fairfax Virginia, 22031, United States
Spokane Washington, 99208, United States
Caba Buenos Aires, C1426, Argentina
Ciudad Autonoma de Buenos Aires Buenos Aires, C1093, Argentina
Cordoba Córdoba, 5000, Argentina
Cordoba Córdoba, X5016, Argentina
Rosario Santa Fe, S2002, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
Buenos Aires , C1122, Argentina
Buenos Aires , C1280, Argentina
Liverpool New South Wales, 2170, Australia
Murdoch Western Australia, 6150, Australia
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Salvador Bahia, 40170, Brazil
Curitiba Paraná, 80440, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Blumenau Santa Catarina, 89010, Brazil
Florianopolis Santa Catarina, 88020, Brazil
Santo Andre São Paulo, 09060, Brazil
Rio de Janeiro , 20231, Brazil
São Paulo , 01409, Brazil
São Paulo , 04014, Brazil
Branipole Village , 4109, Bulgaria
Haskovo , 6300, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1632, Bulgaria
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H3T 1, Canada
Temuco CautÃn, 48008, Chile
Temuco CautÃn, 48102, Chile
Santiago , 75006, Chile
Santiago , 83200, Chile
Lanzhou Gansu, 73003, China
Wuwei Gansu, 73300, China
Guangzhou Guangdong, 51003, China
Guangzhou Guangdong, 51070, China
Shantou Guangdong, 51503, China
Luoyang Henan, 47100, China
Shiyan Hubei, 44200, China
Wuhan City Hubei, 43007, China
Wuhan Hubei, 43000, China
Wuxi Jiangsu, 21412, China
Changchun Jilin, 13002, China
Jinan Shandong, 25001, China
Shanghai Shanghai, 20012, China
Linfen Shanxi, 10003, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Linhai Zhejiang, 31700, China
Lishui Zhejiang, 32300, China
Quzhou Zhejiang, 32400, China
Beijing , 10014, China
Rionegro Antioquia, 05404, Colombia
Valledupar Cesar, 20000, Colombia
Bucaramanga Santander, 68101, Colombia
Pasto , 52000, Colombia
Brno , 656 5, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 4 , 140 5, Czechia
Copenhagen , 2100, Denmark
Tallinn , 13419, Estonia
Amiens Cedex 1 , 80054, France
Avignon cedex 9 , 84918, France
Besançon , 25030, France
Brest , 29200, France
Clermont-Ferrand cedex 1 , 63003, France
Lille Cedex , 59037, France
Lyon cedex 8 , 69373, France
Paris Cedex 14 , 75674, France
Paris , 75015, France
Reims Cedex , 51092, France
Saint Priest en Jarez , 42270, France
Strasbourg cedex , 67065, France
Villejuif , 94805, France
Athens , 11522, Greece
Athens , 11525, Greece
Athens , 11526, Greece
Athens , 11528, Greece
Athens , 18547, Greece
Heraklion - Crete , 71500, Greece
Larissa , 41110, Greece
Patra , 26504, Greece
Thessaloniki , 54007, Greece
Thessaloniki , 54622, Greece
Gyor , 9024, Hungary
Gyula , 5700, Hungary
Miskolc , 3526, Hungary
Nyiregyhaza , 4400, Hungary
Szekszard , 7100, Hungary
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Brescia , 25124, Italy
Catania , 95122, Italy
Lecce , 73100, Italy
Milano , 20162, Italy
Monserrato CA , 09042, Italy
Reggio Emilia , 42100, Italy
Roma , 00168, Italy
Roma , 00184, Italy
Rozzano MI , 20089, Italy
Torino , 10128, Italy
Tricase , 73039, Italy
Udine , 33100, Italy
Verona , 37126, Italy
Nagoya-shi Aichi, 464-8, Japan
Nagoya-shi Aichi, 466-8, Japan
Chiba-shi Chiba, 260-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Matsuyama-shi Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Gifu-shi Gifu, 501-1, Japan
Sapporo Hokkaido, 060-8, Japan
Akashi-shi Hyogo, 673-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Kita-gun Kagawa, 761-0, Japan
Yokohama-shi Kanagawa, 232-0, Japan
Yokohama-shi Kanagawa, 241-8, Japan
Niigata-shi Niigata, 951-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka-shi Osaka, 541-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Koto-ku Tokyo, 135-8, Japan
Daegu , 41404, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Goyang-si Gyeonggi-do , 10408, Korea, Republic of
Incheon , 21431, Korea, Republic of
Jeonju-si, Jeollabuk-do , 54907, Korea, Republic of
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
Riga , 1002, Latvia
Kaunas , 50161, Lithuania
Klaipeda , 92288, Lithuania
Vilnius , 08660, Lithuania
Vilnius , 08661, Lithuania
Kuching Sarawak, 93586, Malaysia
Kuala Lumpur Wilayah Persekutuan, 50586, Malaysia
Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
Guadalajara Jalisco, 44280, Mexico
Zapopan Jalisco, 45070, Mexico
Monterrey Nuevo León, 64570, Mexico
Aguascalientes , 20010, Mexico
Mexico , 06720, Mexico
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Jozefow , 05-41, Poland
Koszalin , 75-58, Poland
Olsztyn , 10-22, Poland
Opole , 45-06, Poland
Poznan , 61-86, Poland
Przemysl , 37-70, Poland
Radom , 26-60, Poland
Coimbra , 3004-, Portugal
Guimaraes , 4835-, Portugal
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Porto , 4200-, Portugal
Santa Maria da Feira , 4520-, Portugal
Baia Mare , 43003, Romania
Bucharest , 02232, Romania
Bucuresti , 02233, Romania
Cluj-Napoca , 40005, Romania
Iasi , 70048, Romania
Ovidiu , 90590, Romania
Singapore , 16858, Singapore
Durban , 4001, South Africa
Gauteng , 2021, South Africa
Johannesburg , 2196, South Africa
Cordoba AndalucÃa, 14004, Spain
Malaga AndalucÃa, 29010, Spain
Zaragoza Aragón, 50009, Spain
Burgos Castilla León, 09006, Spain
Barcelona Cataluña, 08036, Spain
Barcelona Cataluña, 08041, Spain
Sabadell Cataluña, 08208, Spain
Valencia Comunidad Valenciana, 46026, Spain
Ourense Galicia, 32005, Spain
San Sebastian PaÃs Vasco, 20014, Spain
Madrid , 28009, Spain
Madrid , 28220, Spain
Murcia , 30008, Spain
Göteborg , 413 4, Sweden
Stockholm , 141 8, Sweden
Umea , 901 8, Sweden
Kaohsiung , 80756, Taiwan
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Tainan , 70403, Taiwan
Taipei , 11490, Taiwan
Taoyuan , 33305, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 06230, Turkey
Ankara , 06520, Turkey
Ankara , 06800, Turkey
Antalya , 07100, Turkey
Diyarbakir , 21080, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Istanbul , 34722, Turkey
Istanbul , 34865, Turkey
Izmir , 35150, Turkey
Kocaeli , 41380, Turkey
Malatya , 44280, Turkey
Sakarya , 54290, Turkey
Samsun , 55200, Turkey
Van , 65000, Turkey
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