Spots Global Cancer Trial Database for A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
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Trial Identification
Brief Title: A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Official Title: A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Study ID: NCT03816163
Study Description
Brief Summary: The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).
Detailed Description: This study will have a safety lead in phase and a randomization phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph Heritage Medical Group, Fullerton, California, United States
TOI Clinical research, Whittier, California, United States
Midstate Medical Center, Meriden, Connecticut, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
Baptist Health, Miami, Florida, United States
Cancer Treatment Centers of Atlanta, Newnan, Georgia, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Norton Cancer Institute (NCI), Louisville, Kentucky, United States
Ochsner Health System, New Orleans, Louisiana, United States
David C Pratt Cancer Center, Creve Coeur, Missouri, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Northwell Health Cancer Institute, Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Novant Health, Winston-Salem, North Carolina, United States
Houston Methodist Hospital, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
MultiCare Regional Cancer Center - Gig Harbor, Gig Harbor, Washington, United States
Vista Oncology, Olympia, Washington, United States
Virginia Mason, Seattle, Washington, United States
Site AU61008, Gosford, New South Wales, Australia
Site AU61007, Wollongong, New South Wales, Australia
Site AU61005, Fitzroy, Victoria, Australia
Site AU61006, Warrnambool, Victoria, Australia
Site BR55012, Porto Alegre, Rio Grande Do Sul, Brazil
Site BR55009, Centro Passo Fundo, , Brazil
Site BR55008, Rio Grande Do Sul, , Brazil
Site BR55004, Santa Catarina, , Brazil
Site BR55010, Sao Paulo, , Brazil
Site BR55011, Sao Paulo, , Brazil
Site CN86001, Beijing, , China
Site CN86008, Beijing, , China
Site CN86014, Beijing, , China
Site CN86026, Changchun, , China
Site CN86009, Chongqing, , China
Site CN86004, Guangdong, , China
Site CN86020, Guangdong, , China
Site CN86016, Guangzhou, , China
Site CN86012, Harbin, , China
Site CN86002, Hubei, , China
Site CN86005, Jiangsu, , China
Site CN86011, Jiangsu, , China
Site CN86025, Jiangsu, , China
Site CN86024, Shan XI, , China
Site CN86023, Shandong, , China
Site CN86006, Shanghai, , China
Site CN86013, Shanghai, , China
Site CN86019, Shanghai, , China
Site CN86007, Tianjin, , China
Site CN86022, Xinjiang, , China
Site CN86003, Zhejiang, , China
Site CN86018, Zhejiang, , China
Site CN86010, Zhengzhou, , China
Site FR33008, Besancon, Besancon Cedex, France
Site FR33010, Brest, Brest Cedex, France
Site FR33015, Caen, Cedex 5, France
Site FR33006, Chambray, Cedex 9, France
Site FR33012, Herblain, Herblain Cedex, France
Site FR33016, La Chaussee Saint Victor, Loir-et-Cher, France
Site FR33009, Nancy, Nancy Cedex, France
Site FR33017, Rouen, Normandy, France
Site FR33003, Aquitaine, Pessac, France
Site FR33013, Villejuif, Villejuif Cedex, France
Site FR33001, Bayonne Cedex, , France
Site FR33018, Bordeaux, , France
Site FR33002, Grenoble, , France
Site FR33021, Nice Cedex 2, , France
Site FR33023, Pierre Benite, , France
Site FR33014, Plerin, , France
Site FR33005, Pringy Cedex, , France
Site FR33019, Roche-Sur-Yon, , France
Site FR33007, Strasbourg, , France
Site IR35301, Elm Park, Dublin, Ireland
Site IT39006, Rozzano, Milan, Italy
Site IT39004, Candiolo, Torino, Italy
Site IT39002, Cremona, , Italy
Site IT39010, Lombardia, , Italy
Site IT39003, Milan, , Italy
Site IT39014, Toscana, , Italy
Site IT39008, Veneto, , Italy
Site JP81007, Nagoya, Aichi, Japan
Site JP81001, Kashiwa, Chiba, Japan
Site JP81005, Sapporo, Hokkaido, Japan
Site JP81006, Yokohama, Kanagawa, Japan
Site JP81003, Kashihara, Nara, Japan
Site JP81011, Bunkyo-ku, Tokyo, Japan
Site JP81012, Chuo-ku, Tokyo, Japan
Site JP81014, Koto-ku, Tokyo, Japan
Site JP81013, Mitaka, Tokyo, Japan
Site JP81002, Shinjuku-ku, Tokyo, Japan
Site JP81015, Ube, Yamaguchi, Japan
Site JP81004, Fukuoka, , Japan
Site JP81010, Osaka, , Japan
Site JP81009, Wakayama, , Japan
Site KR82005, Seongnam-Si, Gyeonggi-do, Korea, Republic of
Site KR82008, Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82010, Daegu, , Korea, Republic of
Site KR82009, Gyeonggi-do, , Korea, Republic of
Site KR82011, Jeollanam-do, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site MX52004, Distrito Federal, , Mexico
Site MX52003, San Luis Potosi, , Mexico
Site MX52005, Veracruz, , Mexico
Site ES34004, Llobregat, Barcelona, Spain
Site ES34003, Pamplona, Navarra, Spain
Site ES34010, Barcelona, , Spain
Site ES34013, Barcelona, , Spain
Site ES34007, Barcelona, , Spain
Site ES34018, Barcelona, , Spain
Site ES34021, Barcelona, , Spain
Site ES34014, Caceres, , Spain
Site ES34022, Cordoba, , Spain
Site ES34005, Lleida, , Spain
Site ES34015, Madrid, , Spain
Site ES34006, Madrid, , Spain
Site ES34009, Madrid, , Spain
Site ES34026, Malaga, , Spain
Site ES34024, Santander, , Spain
Site ES34017, Santiago de Compostela, , Spain
Site TW88608, New Taipei City, , Taiwan
Site TW88602, Taichung City, , Taiwan
Site TW88601, Taipei City, , Taiwan
Site TW88609, Taipei City, , Taiwan
Site TR90004, Ankara, , Turkey
Site TR90006, Ankara, , Turkey
Site TR90003, Diyarbakir, , Turkey
Site TR90002, Istanbul, , Turkey
Site TR90001, Konya, , Turkey
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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