Spots Global Cancer Trial Database for Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
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Trial Identification
Brief Title: Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
Official Title: A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction
Study ID: NCT01630083
Study Description
Brief Summary: The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction compared to EOX alone. Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical efficacy threshold will be investigated.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site BUL004, Plovdiv, , Bulgaria
Site BUL001, Sofia, , Bulgaria
Site BUL003, Sofia, , Bulgaria
Site BUL005, Sofia, , Bulgaria
Site BUL002, Varna, , Bulgaria
Site CZE002, Olomouc, , Czechia
Site CZE001, Znojmo, , Czechia
Site GER012, Bielefeld, , Germany
Site GER029-01, Bochum, , Germany
Site GER029, Bochum, , Germany
Site GER010, Dresden, , Germany
Site GER001, Essen, , Germany
Site GER017, Frankfurt, , Germany
Site GER005, Halle/Saale, , Germany
Site GER020, Leipzig, , Germany
Site GER016, Münster, , Germany
Site GER013, Pinneberg, , Germany
Site LAT001, Liepaja, , Latvia
Site LAT002, Riga, , Latvia
Site RUS011, Arkhangelsk, , Russian Federation
Site RUS016, Bryansk, , Russian Federation
Site RUS006, Chelyabinsk, , Russian Federation
Site RUS007, Ivanovo, , Russian Federation
Site RUS009, Kursk, , Russian Federation
Site RUS001, Moscow, , Russian Federation
Site RUS017, Novgorod, , Russian Federation
Site RUS002, Obninsk, , Russian Federation
Site RUS023, Omsk, , Russian Federation
Site RUS012, Orel, , Russian Federation
Site RUS014, Orenburg, , Russian Federation
Site RUS005, Pyatigorsk, , Russian Federation
Site RUS019, Ryazan, , Russian Federation
Site RUS003, St.Petersburg, , Russian Federation
Site RUS010, St.Petersburg, , Russian Federation
Site RUS015, St.Petersburg, , Russian Federation
Site RUS013, Yaroslavl, , Russian Federation
Site UKR003, Dnipropetrovsk, , Ukraine
Site UKR001, Donetsk, , Ukraine
Site UKR002, Donetsk, , Ukraine
Site UKR008, Ivano-Frankivsk, , Ukraine
Site UKR005, Kharkiv, , Ukraine
Site UKR007, Kyiv, , Ukraine
Site UKR006, Lviv, , Ukraine
Site UKR015, Poltava, , Ukraine
Site UKR004, Simferopol, , Ukraine
Site UKR011, Sumy, , Ukraine
Site UKR010, Uzhhorod, , Ukraine
Site UKR009, Zaporizhia, , Ukraine
Contact Details
Name: Executive Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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