Spots Global Cancer Trial Database for A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer
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Trial Identification
Brief Title: A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer
Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study ID: NCT03504397
Study Description
Brief Summary: A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.
Detailed Description: The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Phoenix, Arizona, United States
The University of Arizona Medical Center, Tucson, Arizona, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer, Bakersfield, California, United States
City of Hope Nat'l Medical Center, Duarte, California, United States
St. Jude Hospital Yorba Linda, Fullerton, California, United States
Pacific Shores Medical Group, Huntington Beach, California, United States
Loma Linda University, Loma Linda, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California Davis, Sacramento, California, United States
University of California - San Francisco, San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center, Middletown, Connecticut, United States
Memorial Cancer Institute - West, Hollywood, Florida, United States
University of Miami, Miami, Florida, United States
Orlando Health Inc, Orlando, Florida, United States
Memorial Hospital West, Pembroke Pines, Florida, United States
Cancer Treatment Centers of America, Atlanta, Newnan, Georgia, United States
Northwestern University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland Medical Center(UMMC)Transplant Center, Baltimore, Maryland, United States
Maryland Oncology Hematology, Brandywine, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Health Partners Institute, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Montvale, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, Harrison, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Memorial Sloan Kettering Cancer Center, Uniondale, New York, United States
The Ohio State University Medical Center, Columbus, Ohio, United States
Precision Cancer Research -Dayton Physicians Network, Middletown, Ohio, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
Earle A. Chiles Research Institute, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America, Philadelphia, Philadelphia, Pennsylvania, United States
Rhode Island Hospital-Lifespan Cancer Institute, Providence, Rhode Island, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Inova Dwight and Martha Schar Cancer Institute, Fairfax, Virginia, United States
MultiCare Regional Cancer Center - Gig Harbor, Auburn, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Site AU61002, Douglas, Queensland, Australia
Site AU61011, Tugun, Queensland, Australia
Site AU61008, Adelaide, South Australia, Australia
Site AU61006, East Bentleigh, Victoria, Australia
Site AU61007, Kogarah, , Australia
Site BE32007, Edegem, Antwerpen, Belgium
Site BE32001, Bruxelles, Bruxelles-Capitale, Région De, Belgium
Site BE32008, Mons, Hainaut, Belgium
Site BE32002, Bruxelles, Liege, Belgium
Site BE32012, Gent, Oost-Vlaanderen, Belgium
Site BE32006, Leuven, Vlaams Brabant, Belgium
Site BE32005, Brugge, , Belgium
Site BE32004, Brussels, , Belgium
Site BE32011, Charleroi, , Belgium
Site BE32010, Haine-Saint-Paul, , Belgium
Site BR55010, Brasília, Distrito Federal, Brazil
Site BR55006, Lajeado, Rio Grande Do Sul, Brazil
Site BR55002, Itajai, Santa Catarina, Brazil
Site BR55003, Santo Andre, Sao Paulo, Brazil
Site BR55005, Sao Jose do Rio Preto, Sao Paulo, Brazil
Site BR55007, Barretos, São Paulo, Brazil
Site BR55017, Belo Horizonte, , Brazil
Site BR55016, Passo Fundo, , Brazil
Site BR55015, Rio de Janeiro, , Brazil
Site BR55018, Santa Catarina, , Brazil
Site BR55009, São Paulo, , Brazil
Site BR55004, São Paulo, , Brazil
Site CA15005, Edmonton, Alberta, Canada
Site CA15009, Saint-John, New Brunswick, Canada
Site CA15011, Toronto, Ontario, Canada
Site CA15002, Montreal, Quebec, Canada
Site CA15008, Montreal, Quebec, Canada
Site CL56003, Providencia, Santiago, Chile
Site CL56008, Providencia, , Chile
Site CL56005, Santiago, , Chile
Site CL56007, Valdivia, , Chile
Site CN86003, Haerbin, Heilongjiang, China
Site CN86006, Nanjing, Jiangsu, China
Site CN86004, Hangzhou Shi, Zhejiang, China
Site CN86009, Beijing, , China
Site CN86002, Beijing, , China
Site CN86005, Hefei, , China
Site CN86001, Xiamen, , China
Site CN86008, Zhengzhou, , China
Site CO57006, Medellín, Antioquia, Colombia
Site CO57007, Monteria, Córdoba, Colombia
Site CO57009, Bogota, DC, Colombia
Site CO57005, Cali, Valle, Colombia
Site CO57001, Cali, , Colombia
Site CO57002, Medellin, , Colombia
Site FR33009, Dijon, Bourgogne, France
Site FR33010, Brest Cedex, Bretagne, France
Site FR33001, Rennes, Bretagne, France
Site FR33008, Besancon cedex, Franche-Comte, France
Site FR33011, Montpellier Cedex 5, Languedoc-Roussillon, France
Site FR33002, Paris cedex, Paris, France
Site FR33101, St Herblain, Pays-de-la-Loire, France
Site FR33005, Nice, Provence-Alpes-Côte-d'Azur, France
Site FR33003, Lyon, Rhone, France
Site FR33006, Poitiers, Vienne, France
Site FR33103, Creteil, , France
Site FR33007, Nice Cedex 2, , France
Site FR33104, Saint Priest en Jarez, , France
Site DE49008, Munich, Bavaria, Germany
Site DE49007, Munchen, Bayern, Germany
Site DE49002, Mainz, Rheinland-Pfalz, Germany
Site DE49021, Halle, Sachsen-Anhalt, Germany
Site DE49015, Magdeburg, Sachsen-Anhalt, Germany
Site DE49010, Dresden, Sachsen, Germany
Site DE49004, Leipzig, Sachsen, Germany
Site DE49012, Berlin, , Germany
Site DE49011, Berlin, , Germany
Site DE49018, Dresden, , Germany
Site DE49019, Heilbronn, , Germany
Site IL97206, Kfar Saba, HaMerkaz, Israel
Site IL97210, HaDarom, , Israel
Site IL97201, Haifa, , Israel
Site IL97209, Holon, , Israel
Site IL97202, Jerusalem, , Israel
Site IL97203, Tel Aviv, , Israel
Site IT39011, Meldola, Forli, Italy
Site IT39020, Monza, Lombardia, Italy
Site IT39023, Vicenza, VI, Italy
Site IT39013, Ancona, , Italy
Site IT39004, Bergamo, , Italy
Site IT39009, Cremona, , Italy
Site IT39006, Milano, , Italy
Site IT39008, Milano, , Italy
Site IT39021, Modena, , Italy
Site IT39016, Padova, , Italy
Site IT39012, Parma, , Italy
Site IT39018, Perugia, , Italy
Site IT39003, Piacenza, , Italy
Site IT39019, Pisa, , Italy
Site IT39022, Reggio Emilia, , Italy
Site IT39015, Roma, , Italy
Site IT39026, Terni, , Italy
Site IT39024, Turin TO, , Italy
Site JP81009, Nagoya, Aichi, Japan
Site JP81003, Kashiwa, Chiba, Japan
Site JP81002, Matsuyama, Ehime, Japan
Site JP81007, Sapporo, Hokkaido, Japan
Site JP81014, Kobe, Hyogo, Japan
Site JP81001, Suita, Osaka, Japan
Site JP81015, Hidaka, Saitama, Japan
Site JP81010, Kitaadachi-gun, Saitama, Japan
Site JP81012, Sunto-gun, Shizuoka, Japan
Site JP81013, Bunkyo-ku, Tokyo, Japan
Site JP81006, Chuo-ku, Tokyo, Japan
Site JP81008, Koto-ku, Tokyo, Japan
Site JP81005, Fukuoka, , Japan
Site JP81004, Osaka, , Japan
Site JP81011, Osaka, , Japan
Site KR82002, Seongnam-si, Gyeonggi-do, Korea, Republic of
Site KR82009, Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of
Site KR82004, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Site KR82008, Incheon, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site MX52007, Ciudad de México, Distrito Federal, Mexico
Site MX52002, Mexico, Distrito Federal, Mexico
Site MX52010, Veracruz, Ver, Veracruz, Mexico
Site MX52001, Aguascalientes, , Mexico
Site MX52003, Distrito Federal, , Mexico
Site MX52009, Jalisco, , Mexico
Site MX52004, Oaxaca, , Mexico
Site MX52008, San Luis De Potosi, , Mexico
Site PE51004, San Isidro, Lima, Peru
Site PE51003, Arequipa, , Peru
Site PE51005, Lima, , Peru
Site PE51006, Lima, , Peru
Site PE51001, Lima, , Peru
Site PL48004, Lublin, Lubuskie, Poland
Site PL48007, Ostroleka, Mazowieckie, Poland
Site PL48005, Wieliszew, Mazowieckie, Poland
Site PL48002, Brzozow, Podkarpackie, Poland
Site PL48009, Warszawa, , Poland
Site ES34013, Badalona, Barcelona, Spain
Site ES34010, Avila, Castilla Y Leon, Spain
Site ES34011, Alcorcon, Madrid, Spain
Site ES34005, Barcelona, , Spain
Site ES34016, Barcelona, , Spain
Site ES34015, Barcelona, , Spain
Site ES34019, Burgos, , Spain
Site ES34008, Madrid, , Spain
Site ES34017, Madrid, , Spain
Site ES34004, Madrid, , Spain
Site ES34003, Murcia, , Spain
Site ES34018, Sevilla, , Spain
Site ES34006, Zaragoza, , Spain
Site TW88605, Kwei-Shan, Taoyuan, Taiwan
Site TW88608, Kaohsiung, , Taiwan
Site TW88604, Kaohsiung, , Taiwan
Site TW88603, Taichung, , Taiwan
Site TW88607, Tainan, , Taiwan
Site TW88606, Taipei, , Taiwan
Site TW88601, Taipei, , Taiwan
Site GB44003, Aberdeen, Aberdeenshire, United Kingdom
Site GB44101, London, London, City Of, United Kingdom
Site GB44102, Sutton, Surrey, United Kingdom
Site GB44103, Cambridge, , United Kingdom
Site GB44009, Coventry, , United Kingdom
Site GB44104, Dundee, , United Kingdom
Site GB44008, Leeds, , United Kingdom
Site GB44002, London, , United Kingdom
Site GB44004, London, , United Kingdom
Site GB44001, Manchester, , United Kingdom
Contact Details
Name: Global Medical Lead
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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