- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746796
Study of ONO-4538 in Gastric Cancer
ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Akita, Japan
- Akita Clinical Site
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Chiba, Japan
- Chiba Clinical Site2
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Chiba, Japan
- Chiba Clinical Site1
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Fukui, Japan
- Fukui Clinical site
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Fukuoka, Japan
- Fukuoka Clinical Site2
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Fukuoka, Japan
- Fukuoka Clinical Site3
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Fukuoka, Japan
- Fukuoka Clinical Site4
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Fukuoka, Japan
- Fukuoka Clinical Site1
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Fukushima, Japan
- Fukushima Clinical Site
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Hiroshima, Japan
- Hiroshima Clinical Site1
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Hiroshima, Japan
- Hiroshima Clinical Site2
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Hiroshima, Japan
- Hiroshima Clinical Site3
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Kumamoto, Japan
- Kumamoto Clinical Site1
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Kumamoto, Japan
- Kumamoto Clinical Site2
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Kumamoto, Japan
- Kumamoto Clinical Site3
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Kyoto, Japan
- Kyoto Clinical Site1
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Kyoto, Japan
- Kyoto Clinical Site2
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Kyoto, Japan
- Kyoto Clinical Site3
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Niigata, Japan
- Niigata Clinical Site
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Okayama, Japan
- Okayama Clinical site
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Osaka, Japan
- Osaka Clinical Site1
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Osaka, Japan
- Osaka Clinical Site2
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Osaka, Japan
- Osaka Clinical Site3
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Osaka, Japan
- Osaka Clinical Site4
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Shizuoka, Japan
- Shizuoka Clinical site
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Tokushima, Japan
- Tokushima Clinical Site
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Toyama, Japan
- Toyama Clinical Site
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Wakayama, Japan
- Wakayama Clinical Site
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Yamagata, Japan
- Yamagata Clinical Site
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Aichi
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Nagoya, Aichi, Japan
- Aichi Clinical Site
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Aomori
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Hirosaki, Aomori, Japan
- Aomori Clinical Site
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Misawa, Aomori, Japan
- Aomori Clinical Site
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Chiba
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Funabashi, Chiba, Japan
- Chiba Clinical Site
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Kamogawa, Chiba, Japan
- Chiba Clinical Site
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Kashiwa, Chiba, Japan
- Chiba Clinical Site
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Ehime
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Matsuyama, Ehime, Japan
- Ehime Clinical Site1
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Matsuyama, Ehime, Japan
- Ehime Clinical Site2
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Fukuoka
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Iizuka, Fukuoka, Japan
- Fukuoka Clinical site
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Kitakyushu, Fukuoka, Japan
- Fukuoka Clinical Site1
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Kitakyushu, Fukuoka, Japan
- Fukuoka Clinical Site2
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Kurume, Fukuoka, Japan
- Fukuoka Clinical site
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Gifu
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Gifu-shi, Gifu, Japan
- Gifu Clinical site
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Ogaki, Gifu, Japan
- Gifu Clinical site
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Gumma
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Maebashi, Gumma, Japan
- Gumma Clinical Site
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Takasaki, Gumma, Japan
- Gumma Clinical Site
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Gunma
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Ota, Gunma, Japan
- Gunma Clinical Site
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Hiroshima
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Kure, Hiroshima, Japan
- Hiroshima Clinical Site
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Hokkaido
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Hakodate, Hokkaido, Japan
- Hokkaido Clinical site
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Sapporo, Hokkaido, Japan
- Hokkaido Clinical Site2
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Sapporo, Hokkaido, Japan
- Hokkaido Clinical Site1
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Sapporo, Hokkaido, Japan
- Hokkaido Clinical Site3
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Sapporo-shi, Hokkaido, Japan
- Hokkaido Clinical Site4
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Hyogo
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Akashi, Hyogo, Japan
- Hyogo Clinical Site
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Amagasaki, Hyogo, Japan
- Hyogo Clinical Site
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Kobe, Hyogo, Japan
- Hyogo Clinical Site
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Nishinomiya, Hyogo, Japan
- Hyogo Clinical Site
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Ibaraki
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Higashiibaraki-gun, Ibaraki, Japan
- Ibaraki Clinical Site
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Tsuchiura-shi, Ibaraki, Japan
- Ibaraki Clinical Site
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Ishikawa
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Kanazawa, Ishikawa, Japan
- Ishikawa Clinical Site2
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Kanazawa, Ishikawa, Japan
- Ishikawa Clinical Site1
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Iwate
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Morioka, Iwate, Japan
- Iwate Clinical Site
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Kagawa
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Kita-gun, Kagawa, Japan
- Kagawa Clinical Site
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Kanagawa
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Isehara, Kanagawa, Japan
- Kanagawa Clinical Site
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Kamakura, Kanagawa, Japan
- Kanagawa Clinical Site
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Sagamihara, Kanagawa, Japan
- Kanagawa Clinical Site
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Yokohama, Kanagawa, Japan
- Kanagawa Clinical Site2
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Yokohama, Kanagawa, Japan
- Kanagawa Clinical Site3
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Yokohama, Kanagawa, Japan
- Kanagawa Clinical Site1
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Miyagi
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Natori, Miyagi, Japan
- Miyagi Clinical Site
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Osaki, Miyagi, Japan
- Miyagi Clinical Site
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Sendai-shi, Miyagi, Japan
- Miyagi Clinical Site
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Nagano
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Saku, Nagano, Japan
- Nagano Clinical Site
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Nara
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Ikoma, Nara, Japan
- Nara Clinical Site
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Kashihara-shi, Nara, Japan
- Nara Clinical Site
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Okayama
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Kurashiki, Okayama, Japan
- Okayama Clinical site
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Osaka
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Izumi, Osaka, Japan
- Osaka Clinical site
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Osakasayama, Osaka, Japan
- Osaka Clinical site
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Sakai, Osaka, Japan
- Osaka Clinical site
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Suita, Osaka, Japan
- Osaka Clinical site
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Takatsuki, Osaka, Japan
- Osaka Clinical site
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Toyonaka, Osaka, Japan
- Osaka Clinical site
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Saitama
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Hidaka, Saitama, Japan
- Saitama Clinical site
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Kitaadachi-gun, Saitama, Japan
- Saitama Clinical site
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Shizuoka
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Hamamatsu-shi, Shizuoka, Japan
- Shizuoka Clinical site
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Tochigi
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Shimotsuke, Tochigi, Japan
- Tochigi Clinical site
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Utsunomiya, Tochigi, Japan
- Tochigi Clinical site
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Tokyo
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Bunkyo-ku, Tokyo, Japan
- Tokyo Clinical site
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Chuo-ku, Tokyo, Japan
- Tokyo Clinical site
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Fuchu, Tokyo, Japan
- Tokyo Clinical site
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Koto-ku, Tokyo, Japan
- Tokyo Clinical site
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Minato-ku, Tokyo, Japan
- Tokyo Clinical site
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Shinagawa-ku, Tokyo, Japan
- Tokyo Clinical site
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Shinjuku-ku, Tokyo, Japan
- Tokyo Clinical Site1
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Shinjuku-ku, Tokyo, Japan
- Tokyo Clinical Site2
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Tachikawa, Tokyo, Japan
- Tokyo Clinical site
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Tottori
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Yonago, Tottori, Japan
- Tottori Clinical site
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Yamagata
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Sakata, Yamagata, Japan
- Yamagata Clinical Site
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Busan, Korea, Republic of
- Busan Clinical Site
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Daegu, Korea, Republic of
- Daegu Clinical Site 1
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Daegu, Korea, Republic of
- Daegu Clinical Site 2
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Daejeon, Korea, Republic of
- Daejeon Clinical Site
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Gyeonggi-Do, Korea, Republic of
- Gyeonggi-do Clinical Site1
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Gyeonggi-Do, Korea, Republic of
- Gyeonggi-do Clinical Site2
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Gyeonggi-Do, Korea, Republic of
- Gyeonggi-do Clinical Site3
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Gyeonggi-Do, Korea, Republic of
- Gyeonggi-do Clinical Site4
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Gyeonggi-Do, Korea, Republic of
- Gyeonggi-do Clinical Site5
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Gyeongnam, Korea, Republic of
- Gyeongnam Clinical Site
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Incheon, Korea, Republic of
- Incheon Clinical Site
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Jeollabuk-Do, Korea, Republic of
- Jeollabuk-do Clinical Site
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Jeollanam-do, Korea, Republic of
- Jeollanam-do Clinical Site
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Seoul, Korea, Republic of
- Seoul Clinical Site7
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Seoul, Korea, Republic of
- Seoul Clinical Site 1
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Seoul, Korea, Republic of
- Seoul Clinical Site 2
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Seoul, Korea, Republic of
- Seoul Clinical Site 3
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Seoul, Korea, Republic of
- Seoul Clinical Site 4
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Seoul, Korea, Republic of
- Seoul Clinical Site 5
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Seoul, Korea, Republic of
- Seoul Clinical Site 6
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Seoul, Korea, Republic of
- Seoul Clinical Site8
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Seoul, Korea, Republic of
- Seoul Clinical Site9
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Ulsan, Korea, Republic of
- Ulsan Clinical Site
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Kaohsiung, Taiwan
- Kaohsiung Clinical Site2
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Kaohsiung, Taiwan
- Kaohsiung Clinical Site1
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New Taipei, Taiwan
- New Taipei Clinical Site 1
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Taichung, Taiwan
- Taichung Clinical Site 1
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Taichung, Taiwan
- Taichung Clinical Site2
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Tainan, Taiwan
- Tainan Clinical Site2
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Tainan, Taiwan
- Tainan Clinical Site1
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Taipei, Taiwan
- Taipei Clinical Site1
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Taipei, Taiwan
- Taipei Clinical Site2
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Taoyuan, Taiwan
- Taoyuan Clinical Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
- Have measurable lesions as defined in RECIST Guideline Version 1.1
- ECOG PS score 0 or 1
- Have a life expectancy of at least 3 months
Exclusion Criteria:
- Have multiple cancers
- Have a current or past history of severe hypersensitivity to any other antibody products
- Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
- Patients with active, known or suspected autoimmune disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ONO-4538 + SOX Therapy Cohort (Part 1)
ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (BSA) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. |
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Experimental: ONO-4538 + CapeOX Therapy Cohort (Part 1)
ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1200 - 2100 mg bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. |
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Experimental: ONO-4538 + chemotherapy group (Part 2)
With regard to the ONO-4538 + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. |
|
Placebo Comparator: Placebo + Chemotherapy group (Part 2)
With regard to the placebo + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. Placebo solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (central assessment by IRRC) (only Part 2)
Time Frame: Up to study completion (estimated time frame: 48 months)
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Up to study completion (estimated time frame: 48 months)
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Overall survival (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame: Up to 28 days from last dose
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Up to 28 days from last dose
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Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame: Up to 28 days from last dose
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Up to 28 days from last dose
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Objective response rate (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Progression-free survival (assessment by the site investigator)(only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Duration of response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Disease control rate (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Time to response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Best overall response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Percent change in the sum of diameters of target lesions (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
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Up to study completion (estimated time frame: 54 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd
Publications and helpful links
General Publications
- Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.
- Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Capecitabine
- Oxaliplatin
- Nivolumab
- Tegafur
Other Study ID Numbers
- ONO-4538-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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