252
Participants
Start Date
July 19, 2012
Primary Completion Date
January 31, 2019
Study Completion Date
January 31, 2019
epirubicin
Epirubicin will be administered at a dose of 50 mg/m\^2 as a 15-minute intravenous infusion on day 1 of each cycle.
oxaliplatin
Oxaliplatin will be administered at a dose of 130 mg/m\^2 as a 2-hour intravenous infusion on day 1 of each cycle.
capecitabine
The daily dose of capecitabine will be 1250 mg/m\^2. Capecitabine tablets to be given once daily at a dose of 625 mg/m\^2 orally in the evening of day 1 of each cycle and twice daily at a dose of 625 mg/m\^2 orally on days 2 to 21 of each cycle; the morning dose of capecitabine on day 1 of each cycle to be omitted due to administration of zolbetuximab, epirubicin and oxaliplatin.
zolbetuximab
Two different formats of zolbetuximab, comprising different strengths, to be provided. Vials contained 22 mg or 105 mg of zolbetuximab. Prior to administration, zolbetuximab will be reconstituted with 1.1 mL (22 mg zolbetuximab vials) or 5.0 mL (105 mg zolbetuximab vials) water for injection, which will result in a concentration of 20 mg/mL zolbetuximab. The extractable volume per vial will be 1 mL (for 22 mg zolbetuximab vials) or 5 mL (for 105 mg zolbetuximab vials). The reconstituted solution will be further diluted with sodium chloride 0.9% to a final concentration of 2 mg/mL zolbetuximab. Zolbetuximab will be administered as an intravenous infusion over 2 to 3 hours.
Site BUL004, Plovdiv
Site BUL001, Sofia
Site BUL003, Sofia
Site BUL005, Sofia
Site BUL002, Varna
Site CZE002, Olomouc
Site CZE001, Znojmo
Site GER012, Bielefeld
Site GER029-01, Bochum
Site GER029, Bochum
Site GER010, Dresden
Site GER001, Essen
Site GER017, Frankfurt
Site GER005, Halle
Site GER020, Leipzig
Site GER016, Münster
Site GER013, Pinneberg
Site LAT001, Liepāja
Site LAT002, Riga
Site RUS011, Arkhangelsk
Site RUS016, Bryansk
Site RUS006, Chelyabinsk
Site RUS007, Ivanovo
Site RUS009, Kursk
Site RUS001, Moscow
Site RUS002, Obninsk
Site RUS023, Omsk
Site RUS014, Orenburg
Site RUS012, Oryol
Site RUS005, Pyatigorsk
Site RUS019, Ryazan
Site RUS003, Saint Petersburg
Site RUS010, Saint Petersburg
Site RUS015, Saint Petersburg
Site RUS017, Veliky Novgorod
Site RUS013, Yaroslavl
Site UKR003, Dnipropetrovsk
Site UKR001, Donetsk
Site UKR002, Donetsk
Site UKR008, Ivano-Frankivsk
Site UKR005, Kharkiv
Site UKR007, Kyiv
Site UKR006, Lviv
Site UKR015, Poltava
Site UKR004, Simferopol
Site UKR011, Sumy
Site UKR010, Uzhhorod
Site UKR009, Zaporizhia
Astellas Pharma Global Development, Inc.
INDUSTRY