Gastric Cancer Clinical Trial
Official title:
ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
| Verified date | May 2024 |
| Source | Ono Pharmaceutical Co. Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 493 |
| Est. completion date | January 2021 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hyogo Clinical Site | Akashi | Hyogo |
| Japan | Tokyo Clinical Site | Bunkyo-ku | Tokyo |
| Japan | Chiba Clinical Site | Chiba | |
| Japan | Tokyo Clinical Site | Chuo-ku | Tokyo |
| Japan | Fukuoka Clinical Site | Fukuoka | |
| Japan | Fukuoka Clinical Site | Fukuoka | |
| Japan | Gifu Clinical Site | Gifu | |
| Japan | Hiroshima Clinical Site | Hiroshima | |
| Japan | Ishikawa Clinical Site | Kanazawa | Ishikawa |
| Japan | Kanagawa Clinical Site | Kawasaki | Kanagawa |
| Japan | Saitama Clinical Site | Kitaadachi | Saitama |
| Japan | Hyogo Clinical Site | Kobe | Hyogo |
| Japan | Tokyo Clinical Site | Koto-ku | Tokyo |
| Japan | Ehime Clinical Site | Matsuyama | Ehime |
| Japan | Aomori Clinical Site | Misawa | Aomori |
| Japan | Aichi Clinical Site | Nagoya | Aichi |
| Japan | Osaka Clinical Site | Osaka | |
| Japan | Osaka Clinical Site | Osakasayama | Osaka |
| Japan | Kanagawa Clinical Site | Sagamihara | Kanagawa |
| Japan | Nagano Clinical Site | Saku | Nagano |
| Japan | Hokkaido Clinical Site | Sapporo | Hokkaido |
| Japan | Tochigi Clinical Site | Shimotsuke | Tochigi |
| Japan | Tokyo Clinical Site | Shinjuku-ku | Tokyo |
| Japan | Shizuoka Clinical Site | Shizuoka | |
| Japan | Osaka Clinical Site | Suita | Osaka |
| Japan | Shizuoka Clinical Site | Sunto-gun | Shizuoka |
| Japan | Osaka Clinical Site | Takatsuki | Osaka |
| Japan | Kanagawa Clinical Site | Yokohama | Kanagawa |
| Korea, Republic of | Busan-si Clinical Site | Busan-si | |
| Korea, Republic of | Daegu Clinical Site | Daegu | |
| Korea, Republic of | Gyeonggi-Do Clinical Site | Gyeonggi-Do | |
| Korea, Republic of | Gyeonggi-Do Clinical Site | Gyeonggi-Do | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Korea, Republic of | Seoul Clinical Site | Seoul | |
| Taiwan | Kaohsiung Clinical Site | Kaohsiung | |
| Taiwan | Kaohsiung Clinical Site | Kaohsiung | |
| Taiwan | Taichung Clinical Site | Taichung | |
| Taiwan | Tainan Clinical Site | Tainan | |
| Taiwan | Taipei Clinical Site | Taipei | |
| Taiwan | Taipei Clinical Site | Taipei | |
| Taiwan | Taipei Clinical Site | Taipei | |
| Taiwan | Taipei Clinical Site | Taipei | |
| Taiwan | Taoyuan Clinical Site | Taoyuan |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharmaceutical Co. Ltd |
Japan, Korea, Republic of, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle | ||
| Secondary | Progression-free survival | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle | ||
| Secondary | Objective response rate | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle | ||
| Secondary | Duration of response | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle | ||
| Secondary | 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 | ||
| Secondary | Safety will be analyzed through the incidence of laboratory abnormalities | Continuously throughout study treatment and up to 28 days from last dose |
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