Spots Global Cancer Trial Database for A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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
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Trial Identification
Brief Title: A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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
Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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: NCT03653507
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.
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
Pacific Cancer Care, Monterey, California, United States
University of Kansas Cancer Center and Medical Pavilion, Fairway, Kansas, United States
Ochsner Clinic CCOP, New Orleans, Louisiana, United States
New Mexico Oncology Hematology, Albuquerque, New Mexico, United States
Montefiore Medical Center (MMC), Bronx, New York, United States
Weill Cornell Medical College (WCMC), New York, New York, United States
Prisma Health Cancer Institute, Boiling Springs, South Carolina, United States
Parkland Hospital, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology, Houston, Texas, United States
Utah Cancer Specialist, Salt Lake City, Utah, United States
Site AR54009, Buenos Aires, , Argentina
Site AR54006, Pergamino, , Argentina
Site AR54001, San Miguel De Tucuman, , Argentina
Site AR54004, San Miguel de Tucumán, , Argentina
Site AR54003, Viedma, , Argentina
Site CA15003, Chicoutimi, Quebec, Canada
Site CA15002, Rimouski, Quebec, Canada
Site CA15004, Calgary, , Canada
Site CN86034, Fuzhou, Fujian, China
Site CN86037, Fuzhou, Fujian, China
Site CN86032, Haikou, Hainan, China
Site CN86012, Zhengzhou, Henan, China
Site CN86029, Changsha, Hunan, China
Site CN86043, Hengyang, Hunan, China
Site CN86027, Suzhou, Jiangsu, China
Site CN86046, Wuxi, Jiangsu, China
Site CN86007, Hangzhou, Zhejiang, China
Site CN86044, Baoding, , China
Site CN86035, Beijing, , China
Site CN86050, Beijing, , China
Site CN86025, Bengbu, , China
Site CN86002, Changchun, , China
Site CN86049, Changchun, , China
Site CN86053, Changchun, , China
Site CN86021, Changzhou, , China
Site CN86039, Chengdu, , China
Site CN86052, Dalian, , China
Site CN86054, Dalian, , China
Site CN86015, Fuzhou, , China
Site CN86001, Guangzhou, , China
Site CN86042, Guangzhou, , China
Site CN86051, Haebrin, , China
Site CN86036, Hangzhou, , China
Site CN86038, Linyi, , China
Site CN86016, Nanjing, , China
Site CN86045, Nanning, , China
Site CN86014, Shanghai, , China
Site CN86026, Shantou, , China
Site CN86047, Shenyang, , China
Site CN86017, Shijiazhuang, , China
Site CN86009, Tianjin, , China
Site CN86040, Tianjin, , China
Site CN86031, Urumchi, , China
Site CN86004, Wuhan, , China
Site CN86005, Wuhan, , China
Site CN86013, Xi'an, , China
Site CN86030, Xiamen, , China
Site CN86011, Xuzhou, , China
Site CN86024, Zhengzhou, , China
Site HR38501, Varazdin, , Croatia
Site HR38502, Zagreb, , Croatia
Site HR38503, Zagreb, , Croatia
Site GR30001, Athens, , Greece
Site GR30004, Heraklion, , Greece
Site GR30003, Larissa, , Greece
Site GR30005, Neo Faliro, Piraeus, , Greece
Site GR30007, Rio Patras, , Greece
Site GR30002, Thessaloniki, , Greece
Site GR30006, Thessaloniki, , Greece
Site IE35301, Dublin, , Ireland
Site IE35302, Dublin, , Ireland
Site JP81007, Fukuoka-shi, Fukuoka, Japan
Site JP81008, Akashi, Hyogo, Japan
Site JP81004, Kita-gun, Kagawa, Japan
Site JP81003, Kawasaki, Kanagawa, Japan
Site JP81001, Yokohama, Kanagawa, Japan
Site JP81010, Suita, Osaka, Japan
Site JP81005, Utsunomiya, Tochigi, Japan
Site JP81002, Chiba, , Japan
Site JP81006, Kashiwa, , Japan
Site JP81012, Koto-ku, , Japan
Site JP81009, Matsuyama, , Japan
Site JP81011, Tsukiji, , Japan
Site KR82002, Daegu, , Korea, Republic of
Site KR82006, Goyang-si, , Korea, Republic of
Site KR82007, Gyeonggi-do, , Korea, Republic of
Site KR82014, Incheon, , Korea, Republic of
Site KR82008, Jeollanam-do, , Korea, Republic of
Site KR82010, Jeonju-si, , Korea, Republic of
Site KR82011, Seongnam-si, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82012, Seoul, , Korea, Republic of
Site KR82013, Seoul, , Korea, Republic of
Site KR82015, Seoul, , Korea, Republic of
Site KR82009, Suwon, , Korea, Republic of
Site MY60001, Georgetown, , Malaysia
Site MY60004, Kota Kinabalu, , Malaysia
Site MY60002, Kuala Lumpur, , Malaysia
Site MY60003, Kuala Lumpur, , Malaysia
Site MY60005, Kuala Lumpur, , Malaysia
Site NL31004, Groningen, , Netherlands
Site NL31003, Tilburg, , Netherlands
Site PT35109, Braga, , Portugal
Site PT35110, Coimbra, , Portugal
Site PT35111, Guimaraes, , Portugal
Site PT35102, Lisboa, , Portugal
Site PT35106, Lisboa, , Portugal
Site PT35105, Porto, , Portugal
Site PT35108, Porto, , Portugal
Site PT35104, Santa Maria da Feira, , Portugal
Site PT35101, Setubal, , Portugal
Site PT35107, Vila Real, , Portugal
Site RO40002, Bucharest, , Romania
Site RO40005, Cluj-Napoca, , Romania
Site RO40007, Cluj-Napoca, , Romania
Site RO40003, Craiova, , Romania
Site RO40004, Floresti, , Romania
Site RO40001, Iasi, , Romania
Site RO40006, Iasi, , Romania
Site RO40008, Timisoara, , Romania
Site ES34006, Barcelona, , Spain
Site ES34009, Barcelona, , Spain
Site ES34010, Barcelona, , Spain
Site ES34005, Coruña, , Spain
Site ES34001, Elche, , Spain
Site ES34002, Madrid, , Spain
Site ES34003, Madrid, , Spain
Site ES34008, Madrid, , Spain
Site ES34013, Madrid, , Spain
Site ES34011, Malaga, , Spain
Site ES34004, Pamplona, , Spain
Site ES34007, Valencia, , Spain
Site ES34012, Valencia, , Spain
Site TW88602, Kaohsiung, , Taiwan
Site TW88603, Taichung, , Taiwan
Site TW88604, Taipei, , Taiwan
Site TW88605, Tianan, , Taiwan
Site TH66002, Bangkok, , Thailand
Site TH66005, Bangkok, , Thailand
Site TH66007, Bangkok, , Thailand
Site TH66009, Bangkok, , Thailand
Site TH66011, Laksi, , Thailand
Site TH66001, Muang, , Thailand
Site TH66003, Muang, , Thailand
Site TH66006, Pathumthani, , Thailand
Site TH66010, Pathumwan, , Thailand
Site TH66004, Songkla, , Thailand
Site TH66008, Watthana, , Thailand
Site TR90008, Pendik, Istanbul, Turkey
Site TR90003, Atakum, , Turkey
Site TR90004, Balcali, , Turkey
Site TR90012, Bornova, , Turkey
Site TR90001, Bursa, , Turkey
Site TR90002, Istanbul, , Turkey
Site TR90010, Istanbul, , Turkey
Site TR90015, Istanbul, , Turkey
Site TR90013, Konyaalti, , Turkey
Site TR90007, Konya, , Turkey
Site TR90011, Malatya, , Turkey
Site GB44004, Cardiff, Wales, United Kingdom
Site GB44002, Bristol, , United Kingdom
Site GB44001, London, , United Kingdom
Site GB44005, Northwood, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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