Study of ONO-4538 in Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT02746796
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4538 + SOX Therapy Cohort (Part 1) ONO-4538 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. ONO-4538 + chemotherapy group (Part 2) ONO-4538 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 + Chemotherapy group (Part 2) Tegafur- Gimeracil-Oteracil potassium 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. Placebo + Chemotherapy group (Part 2) Placebo 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. ONO-4538 + SOX Therapy Cohort (Part 1) Tegafur- Gimeracil-Oteracil potassium 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. ONO-4538 + chemotherapy group (Part 2) Tegafur- Gimeracil-Oteracil potassium 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. ONO-4538 + CapeOX Therapy Cohort (Part 1) ONO-4538 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. Placebo + Chemotherapy group (Part 2) Oxaliplatin 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. ONO-4538 + SOX Therapy Cohort (Part 1) Oxaliplatin 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. ONO-4538 + CapeOX Therapy Cohort (Part 1) Oxaliplatin 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. ONO-4538 + CapeOX Therapy Cohort (Part 1) Capecitabine 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. ONO-4538 + chemotherapy group (Part 2) Oxaliplatin 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. ONO-4538 + chemotherapy group (Part 2) Capecitabine 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 + Chemotherapy group (Part 2) Capecitabine 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.
- Primary Outcome Measures
Name Time Method Progression-free survival (central assessment by IRRC) (only Part 2) Up to study completion (estimated time frame: 48 months) Overall survival (only Part 2) Up to study completion (estimated time frame: 54 months)
- Secondary Outcome Measures
Name Time Method Objective response rate (only Part 2) Up to study completion (estimated time frame: 54 months) Progression-free survival (assessment by the site investigator)(only Part 2) Up to study completion (estimated time frame: 54 months) Duration of response (only Part 2) Up to study completion (estimated time frame: 54 months) Disease control rate (only Part 2) Up to study completion (estimated time frame: 54 months) Time to response (only Part 2) Up to study completion (estimated time frame: 54 months) Best overall response (only Part 2) Up to study completion (estimated time frame: 54 months) Percent change in the sum of diameters of target lesions (only Part 2) Up to study completion (estimated time frame: 54 months) Safety will be analyzed through the incidence of adverse events, serious adverse events Up to 28 days from last dose Safety will be analyzed through the incidence of laboratory abnormalities Up to 28 days from last dose
Trial Locations
- Locations (97)
Tokyo Clinical Site2
🇯🇵Shinjuku-ku, Tokyo, Japan
Tainan Clinical Site1
🇨🇳Tainan, Taiwan
Tainan Clinical Site2
🇨🇳Tainan, Taiwan
Tokyo Clinical Site
🇯🇵Tachikawa, Tokyo, Japan
Fukushima Clinical Site
🇯🇵Fukushima, Japan
Kumamoto Clinical Site1
🇯🇵Kumamoto, Japan
Kyoto Clinical Site1
🇯🇵Kyoto, Japan
Kyoto Clinical Site3
🇯🇵Kyoto, Japan
Jeollanam-do Clinical Site
🇰🇷Jeollanam-do, Korea, Republic of
Ehime Clinical Site1
🇯🇵Matsuyama, Ehime, Japan
Aichi Clinical Site
🇯🇵Nagoya, Aichi, Japan
Gunma Clinical Site
🇯🇵Ota, Gunma, Japan
Gifu Clinical Site
🇯🇵Ogaki, Gifu, Japan
Chiba Clinical Site
🇯🇵Kashiwa, Chiba, Japan
Hokkaido Clinical Site4
🇯🇵Sapporo-shi, Hokkaido, Japan
Akita Clinical Site
🇯🇵Akita, Japan
Fukuoka Clinical Site2
🇯🇵Fukuoka, Japan
Hiroshima Clinical Site
🇯🇵Kure, Hiroshima, Japan
Hokkaido Clinical Site
🇯🇵Hakodate, Hokkaido, Japan
Ishikawa Clinical Site1
🇯🇵Kanazawa, Ishikawa, Japan
Kanagawa Clinical Site2
🇯🇵Yokohama, Kanagawa, Japan
Fukuoka Clinical Site1
🇯🇵Fukuoka, Japan
Kanagawa Clinical Site3
🇯🇵Yokohama, Kanagawa, Japan
Kagawa Clinical Site
🇯🇵Kita-gun, Kagawa, Japan
Chiba Clinical Site1
🇯🇵Chiba, Japan
Chiba Clinical Site2
🇯🇵Chiba, Japan
Hokkaido Clinical Site3
🇯🇵Sapporo, Hokkaido, Japan
Ibaraki Clinical Site
🇯🇵Tsuchiura-shi, Ibaraki, Japan
Ishikawa Clinical Site2
🇯🇵Kanazawa, Ishikawa, Japan
Fukui Clinical Site
🇯🇵Fukui, Japan
Nagano Clinical Site
🇯🇵Saku, Nagano, Japan
Okayama Clinical Site
🇯🇵Okayama, Japan
Fukuoka Clinical Site4
🇯🇵Fukuoka, Japan
Yamagata Clinical Site
🇯🇵Yamagata, Japan
Fukuoka Clinical Site3
🇯🇵Fukuoka, Japan
Kumamoto Clinical Site2
🇯🇵Kumamoto, Japan
Kumamoto Clinical Site3
🇯🇵Kumamoto, Japan
Toyama Clinical Site
🇯🇵Toyama, Japan
Seoul Clinical Site 2
🇰🇷Seoul, Korea, Republic of
Kaohsiung Clinical Site2
🇨🇳Kaohsiung, Taiwan
Gumma Clinical Site
🇯🇵Takasaki, Gumma, Japan
Kanagawa Clinical Site
🇯🇵Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site1
🇯🇵Yokohama, Kanagawa, Japan
Shizuoka Clinical Site
🇯🇵Shizuoka, Japan
Saitama Clinical Site
🇯🇵Kitaadachi-gun, Saitama, Japan
Hiroshima Clinical Site2
🇯🇵Hiroshima, Japan
Hiroshima Clinical Site3
🇯🇵Hiroshima, Japan
Seoul Clinical Site 5
🇰🇷Seoul, Korea, Republic of
Kaohsiung Clinical Site1
🇨🇳Kaohsiung, Taiwan
Taoyuan Clinical Site
🇨🇳Taoyuan, Taiwan
Ehime Clinical Site2
🇯🇵Matsuyama, Ehime, Japan
Fukuoka Clinical Site
🇯🇵Kurume, Fukuoka, Japan
Hyogo Clinical Site
🇯🇵Nishinomiya, Hyogo, Japan
Hokkaido Clinical Site1
🇯🇵Sapporo, Hokkaido, Japan
Miyagi Clinical Site
🇯🇵Sendai-shi, Miyagi, Japan
Iwate Clinical Site
🇯🇵Morioka, Iwate, Japan
Tochigi Clinical Site
🇯🇵Utsunomiya, Tochigi, Japan
Nara Clinical Site
🇯🇵Kashihara-shi, Nara, Japan
Tokyo Clinical Site1
🇯🇵Shinjuku-ku, Tokyo, Japan
Tottori Clinical Site
🇯🇵Yonago, Tottori, Japan
Hiroshima Clinical Site1
🇯🇵Hiroshima, Japan
Kyoto Clinical Site2
🇯🇵Kyoto, Japan
Niigata Clinical Site
🇯🇵Niigata, Japan
Osaka Clinical Site2
🇯🇵Osaka, Japan
Osaka Clinical Site4
🇯🇵Osaka, Japan
Osaka Clinical Site3
🇯🇵Osaka, Japan
Tokushima Clinical Site
🇯🇵Tokushima, Japan
Daegu Clinical Site 2
🇰🇷Daegu, Korea, Republic of
Wakayama Clinical Site
🇯🇵Wakayama, Japan
Gyeonggi-Do Clinical Site1
🇰🇷Gyeonggi-Do, Korea, Republic of
Daejeon Clinical Site
🇰🇷Daejeon, Korea, Republic of
Gyeonggi-Do Clinical Site2
🇰🇷Gyeonggi-Do, Korea, Republic of
Gyeonggi-Do Clinical Site3
🇰🇷Gyeonggi-Do, Korea, Republic of
Gyeongnam Clinical Site
🇰🇷Gyeongnam, Korea, Republic of
Gyeonggi-Do Clinical Site5
🇰🇷Gyeonggi-Do, Korea, Republic of
Gyeonggi-Do Clinical Site4
🇰🇷Gyeonggi-Do, Korea, Republic of
Incheon Clinical Site
🇰🇷Incheon, Korea, Republic of
Jeollabuk-Do Clinical Site
🇰🇷Jeollabuk-Do, Korea, Republic of
Seoul Clinical Site 1
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 6
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 4
🇰🇷Seoul, Korea, Republic of
New Taipei Clinical Site 1
🇨🇳New Taipei, Taiwan
Taichung Clinical Site 1
🇨🇳Taichung, Taiwan
Taichung Clinical Site2
🇨🇳Taichung, Taiwan
Taipei Clinical Site1
🇨🇳Taipei, Taiwan
Taipei Clinical Site2
🇨🇳Taipei, Taiwan
Seoul Clinical Site 3
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site9
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site8
🇰🇷Seoul, Korea, Republic of
Hokkaido Clinical Site2
🇯🇵Sapporo, Hokkaido, Japan
Osaka Clinical Site
🇯🇵Toyonaka, Osaka, Japan
Daegu Clinical Site 1
🇰🇷Daegu, Korea, Republic of
Aomori Clinical Site
🇯🇵Misawa, Aomori, Japan
Osaka Clinical Site1
🇯🇵Osaka, Japan
Seoul Clinical Site7
🇰🇷Seoul, Korea, Republic of
Busan Clinical Site
🇰🇷Busan, Korea, Republic of
Ulsan Clinical Site
🇰🇷Ulsan, Korea, Republic of