胃癌におけるONO-4538の研究

基本情報

NCT ID: NCT02746796
ステータス: 完了
試験のフェーズ: 第2/第3相
試験タイプ: 介入
目標被験者数: 680
治験依頼者名: Ono Pharmaceutical Co. Ltd

概要

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.

対象疾患

Gastric Cancer

介入

ONO-4538(DRUG)

Oxaliplatin(DRUG)

Tegafur- Gimeracil-Oteracil potassium(DRUG)

Capecitabine(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

小野薬品工業株式会社(INDUSTRY)