Last updated on May 2018

Study of ONO-4538 in Gastric Cancer


Brief description of study

The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.

Clinical Study Identifier: NCT02746796

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Ono Pharmaceutical Co. Ltd Corporate ...

Kumamoto Clinical Site1
Kumamoto, Japan

Ono Pharmaceutical Co. Ltd Corporate ...

Kumamoto Clinical Site2
Kumamoto, Japan

Ono Pharmaceutical Co. Ltd Corporate ...

Kumamoto Clinical Site3
Kumamoto, Japan