Study Details

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Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01630083

Astellas Study ID

The unique identification code given by the study sponsor.

GM-IMAB-001-03

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-005285-38

Follow Trial

Condition

Stomach or Esophageal Cancer

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2012 - Jan 2019

Masking

Not Available

Enrollment number

252

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 summary

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Locations

Site UKR015

Poltava, Ukraine

Site GER010

Dresden, Germany

Site RUS005

Pyatigorsk, Russian Federation

Site GER019

Freiburg, Germany

Site GER011

Lebach, Germany

Site RUS001

Moscow, Russian Federation

Site BUL002

Varna, Bulgaria

Site RUS019

Ryazan, Russian Federation

Site RUS012

Orel, Russian Federation

Site UKR001

Donetsk, Ukraine

Site GER013

Pinneberg, Germany

Site RUS014

Orenburg, Russian Federation

Site LAT003

Daugavpils, Latvia

Site RUS013

Yaroslavl, Russian Federation

Site GER017

Frankfurt, Germany

Site UKR009

Zaporizhia, Ukraine

Site BUL004

Plovdiv, Bulgaria

Site UKR010

Uzhhorod, Ukraine

Site GER029-01

Bochum, Germany

Site UKR006

Lviv, Ukraine

Site LAT002

Riga, Latvia

Site UKR002

Donetsk, Ukraine

Site BUL001

Sofia, Bulgaria

Site GER001

Essen, Germany

Site BUL003

Sofia, Bulgaria

Site GER020

Leipzig, Germany

Site RUS007

Ivanovo, Russian Federation

Site CZE002

Olomouc, Czech Republic

Site RUS016

Bryansk, Russian Federation

Site CZE003

Prague, Czech Republic

Site RUS004

Ekaterinburg, Russian Federation

Site UKR007

Kyiv, Ukraine

Site BUL005

Sofia, Bulgaria

Site RUS002

Obninsk, Russian Federation

Site RUS003

St.Petersburg, Russian Federation

Site RUS017

Novgorod, Russian Federation

Site GER029

Bochum, Germany

Site CZE001

Znojmo, Czech Republic

Site RUS025

St. Petersburg, Russian Federation

Site RUS006

Chelyabinsk, Russian Federation

Site GER016

Münster, Germany

Site GER012

Bielefeld, Germany

Site UKR005

Kharkiv, Ukraine

Site RUS010

St.Petersburg, Russian Federation

Site RUS015

St.Petersburg, Russian Federation

Site GER018

Stade, Germany

Site RUS011

Arkhangelsk, Russian Federation

Site RUS023

Omsk, Russian Federation

Site RUS009

Kursk, Russian Federation

Site GER005

Halle/Saale, Germany

Site UKR004

Simferopol, Ukraine

Site UKR011

Sumy, Ukraine

Site LAT001

Liepaja, Latvia

Site UKR008

Ivano-Frankivsk, Ukraine

Site UKR003

Dnipropetrovsk, Ukraine

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