565
Participants
Start Date
June 21, 2018
Primary Completion Date
September 9, 2022
Study Completion Date
March 31, 2026
zolbetuximab
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Each cycle was approximately 42 days.
placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
oxaliplatin
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1, 15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42 days.
folinic acid
Participants received up to 12 treatments of folinic acid administered 400 mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and 29 of each cycle. participants could continue to receive folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
fluorouracil
Participants received up to 12 treatments of 5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Site TW88601, Taipei
Site TW88605, Kwei-Shan
Site TW88603, Taichung
Site CO57006, Medellín
Site TW88607, Tainan City
Site TW88604, Kaohsiung City
Site BE32004, Brussels
Site BE32002, Brussels
Site DE49018, Dresden
Site BE32001, Brussels
Site AU61007, Kogarah
Site BE32007, Edegem
Site BE32006, Leuven
Site MX52007, Mexico City
Site AU61006, East Bentleigh
Site PE51003, Arequipa
Site AU61011, Tugun
Site AU61002, Douglas
Site AU61008, Adelaide
Site IT39026, Terni
Site BE32011, Charleroi
Site KR82006, Seoul
Site BE32008, Mons
Site BE32010, Haine-Saint-Paul
Site BE32005, Bruges
Site BE32012, Ghent
Site TW88606, Taipei
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Cancer Center, Harrison
Memorial Sloan Kettering Cancer Center, Uniondale
Memorial Sloan Kettering Cancer Center, Commack
Site DE49012, Berlin
Site DE49011, Berlin
Site KR82002, Seongnam-si
Roswell Park Cancer Institute, Buffalo
Site PE51005, Lima
Site PE51006, Lima
Site KR82009, Suwon
Lancaster General Hospital, Lancaster
Thomas Jefferson University, Philadelphia
Cancer Treatment Centers of America, Philadelphia, Philadelphia
Site IT39020, Monza
Site IT39006, Milan
Site IT39008, Milan
Site MX52001, Aguascalientes
Maryland Oncology Hematology, Brandywine
Site FR33009, Dijon
University of Maryland Medical Center(UMMC)Transplant Center, Baltimore
Site KR82008, Incheon
Inova Dwight and Martha Schar Cancer Institute, Fairfax
Site IT39004, Bergamo
Site FR33008, Besançon
Site IT39009, Cremona
Site ES34008, Madrid
Site ES34017, Madrid
Site ES34004, Madrid
Site ES34011, Alcorcón
Site IT39003, Piacenza
Site FR33010, Brest
Site ES34003, Murcia
Cancer Treatment Centers of America, Atlanta, Newnan
Orlando Health Inc, Orlando
Memorial Cancer Institute - West, Hollywood
Memorial Hospital West, Pembroke Pines
University of Miami, Miami
Site FR33011, Montpellier
Site FR33001, Rennes
Site IT39016, Padua
Site IT39023, Vicenza
Site DE49015, Magdeburg
Norton Cancer Institute, Louisville
Site ES34018, Seville
Site IT39021, Modena
Site IT39022, Reggio Emilia
Site FR33104, Saint-Priest-en-Jarez
Site IT39012, Parma
The Ohio State University Medical Center, Columbus
Site IL97206, Kfar Saba
Site FR33101, Saint-Herblain
Site MX52009, Jalisco
Precision Cancer Research -Dayton Physicians Network, Middletown
Site IT39011, Meldola
Karmanos Cancer Institute, Detroit
Site ES34006, Zaragoza
Regions Hospital, Saint Paul
Site DE49002, Mainz
Health Partners Institute, Saint Louis Park
Site IT39019, Pisa
Sanford Cancer Center, Sioux Falls
Site IL97209, Holon
Site IT39013, Ancona
Northwestern University Medical Center, Chicago
University of Chicago, Chicago
Site IL97203, Tel Aviv
Site FR33003, Lyon
University of Oklahoma Health Science Center, Oklahoma City
Site DE49019, Heilbronn
Site FR33002, Paris
The University of Texas MD Anderson Cancer Center, Houston
Site MX52008, San Luis de Potosi
University of Colorado, Aurora
Site TW88608, Kaohsiung City
Site DE49008, Munich
Site DE49007, München
University of Arizona, Phoenix
The University of Arizona Medical Center, Tucson
Site FR33006, Poitiers
The Angeles Clinic and Research Institute, Los Angeles
City of Hope Nat'l Medical Center, Duarte
Site IL97202, Jerusalem
Site MX52010, Veracruz, Ver
Loma Linda University, Loma Linda
Pacific Shores Medical Group, Huntington Beach
St. Jude Hospital Yorba Linda, Fullerton
CBCC Global Research, Inc. at Comprehensive Blood and Cancer, Bakersfield
Site FR33103, Créteil
University of California - San Francisco, San Francisco
University of California Davis, Sacramento
Earle A. Chiles Research Institute, Portland
Oregon Health & Science University, Portland
Seattle Cancer Care Alliance, Seattle
MultiCare Regional Cancer Center - Gig Harbor, Auburn
Site CN86009, Beijing
Site CN86002, Beijing
Site CO57009, Bogotá
Site CN86003, Haerbin
Site CN86006, Nanjing
Site CO57007, Montería
Site CN86005, Hefei
Site CN86004, Hangzhou
Site CN86008, Zhengzhou
Site IL97201, Haifa
Site CL56007, Valdivia
Site IL97210, HaDarom
Site CL56003, Providencia
Site CL56008, Providencia
Site CL56005, Santiago
Site BR55006, Lajeado
Memorial Sloan Kettering Cancer Center, Middletown
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
Memorial Sloan Kettering Cancer Center, Basking Ridge
Memorial Sloan Kettering Cancer Center, Montvale
Mount Sinai School of Medicine, New York
Stony Brook University Medical Center, Stony Brook
Rhode Island Hospital-Lifespan Cancer Institute, Providence
Site BR55010, Brasília
Site BR55002, Itajaí
Site BR55007, Barretos
Site BR55003, Santo André
Site BR55005, São José do Rio Preto
Site BR55017, Belo Horizonte
Site BR55016, Passo Fundo
Site BR55015, Rio de Janeiro
Site BR55018, Santa Catarina
Site BR55009, São Paulo
Site BR55004, São Paulo
Site CA15005, Edmonton
Site CA15009, Saint John
Site CA15011, Toronto
Site CA15002, Montreal
Site CA15008, Montreal
Site CN86001, Xiamen
Site CO57005, Santiago de Cali
Site CO57001, Santiago de Cali
Site JP81009, Nagoya
Site JP81003, Kashiwa
Site JP81002, Matsuyama
Site JP81007, Sapporo
Site JP81014, Kobe
Site JP81001, Suita
Site JP81015, Hidaka
Site JP81010, Kitaadachi-gun
Site JP81012, Sunto-gun
Site JP81013, Bunkyo-ku
Site JP81006, Chuo-ku
Site JP81008, Koto-ku
Site JP81005, Fukuoka
Site JP81004, Osaka
Site JP81011, Osaka
Site MX52004, Oaxaca City
Site CO57002, Medellín
Site FR33005, Nice
Site FR33007, Nice
Site DE49010, Dresden
Site DE49004, Leipzig
Site DE49021, Halle
Site IT39018, Perugia
Site IT39015, Roma
Site IT39024, Turin to
Site MX52002, Mexico City
Site MX52003, Distrito Federal
Site PE51004, San Isidro
Site PE51001, Lima
Site PL48004, Lublin
Site PL48007, Ostrołęka
Site PL48005, Wieliszew
Site PL48002, Brzozów
Site PL48009, Warsaw
Site KR82004, Seoul
Site KR82003, Seoul
Site KR82005, Seoul
Site KR82007, Seoul
Site ES34013, Badalona
Site ES34010, Ávila
Site ES34005, Barcelona
Site ES34016, Barcelona
Site ES34015, Barcelona
Site ES34019, Burgos
Site GB44003, Aberdeen
Site GB44101, London
Site GB44102, Sutton
Site GB44103, Cambridge
Site GB44009, Coventry
Site GB44104, Dundee
Site GB44008, Leeds
Site GB44002, London
Site GB44004, London
Site GB44001, Manchester
Astellas Pharma Global Development, Inc.
INDUSTRY