Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
- Registration Number
- NCT02267343
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- Men & women ≥20 years of age
- Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
- Histologically confirmed adenocarcinoma
- Refractory to or intolerant of standard therapy
- ECOG Performance Status score 0 or 1
- A life expectancy of at least 3 months
- Current or past history of severe hypersensitivity to any other antibody products
- Patients with multiple primary cancers
- 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 Arm ONO-4538 ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Placebo Arm Placebo Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- Primary Outcome Measures
Name Time Method Overall survival Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
- Secondary Outcome Measures
Name Time Method Duration of response Up to study completion (estimated time frame: 30 months), every 6 weeks in principle Progression-free survival Up to study completion (estimated time frame: 30 months), every 2 weeks in principle Objective response rate Up to study completion (estimated time frame: 30 months), every 6 weeks in principle Safety will be analyzed through the incidence of adverse events, serious adverse events Continuously throughout study treatment and up to 28 days from last dose Safety will be analyzed through the incidence of laboratory abnormalities Continuously throughout study treatment and up to 28 days from last dose
Trial Locations
- Locations (26)
Kaohsiung Clinical Site
🇨🇳Kaohsiung, Taiwan
Chiba Clinical Site
🇯🇵Chiba, Japan
Ehime Clinical Site
🇯🇵Matsuyama, Ehime, Japan
Hokkaido Clinical Site
🇯🇵Sapporo, Hokkaido, Japan
Osaka Clinical Site
🇯🇵Osaka, Japan
Fukuoka Clinical Site
🇯🇵Fukuoka, Japan
Hiroshima Clinical Site
🇯🇵Hiroshima, Japan
Daegu Clinical Site
🇰🇷Daegu, Korea, Republic of
Taichung Clinical Site
🇨🇳Taichung, Taiwan
Ishikawa Clinical Site
🇯🇵Kanazawa, Ishikawa, Japan
Saitama Clinical Site
🇯🇵Kitaadachi, Saitama, Japan
Tochigi Clinical Site
🇯🇵Shimotsuke, Tochigi, Japan
Gifu Clinical Site
🇯🇵Gifu, Japan
Busan-si Clinical Site
🇰🇷Busan-si, Korea, Republic of
Gyeonggi-Do Clinical Site
🇰🇷Gyeonggi-Do, Korea, Republic of
Tainan Clinical Site
🇨🇳Tainan, Taiwan
Taoyuan Clinical Site
🇨🇳Taoyuan, Taiwan
Seoul Clinical Site
🇰🇷Seoul, Korea, Republic of
Tokyo Clinical Site
🇯🇵Shinjuku-ku, Tokyo, Japan
Aichi Clinical Site
🇯🇵Nagoya, Aichi, Japan
Aomori Clinical Site
🇯🇵Misawa, Aomori, Japan
Hyogo Clinical Site
🇯🇵Kobe, Hyogo, Japan
Kanagawa Clinical Site
🇯🇵Yokohama, Kanagawa, Japan
Nagano Clinical Site
🇯🇵Saku, Nagano, Japan
Shizuoka Clinical Site
🇯🇵Shizuoka, Japan
Taipei Clinical Site
🇨🇳Taipei, Taiwan