Gastric Cancer Clinical Trial
Official title:
ONO-4538 Phase II/III Study A Multicenter, 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 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.
| Status | Completed |
| Enrollment | 680 |
| Est. completion date | November 17, 2022 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hyogo Clinical Site | Akashi | Hyogo |
| Japan | Akita Clinical Site | Akita | |
| Japan | Hyogo Clinical Site | Amagasaki | Hyogo |
| Japan | Tokyo Clinical Site | Bunkyo-ku | Tokyo |
| Japan | Chiba Clinical Site1 | Chiba | |
| Japan | Chiba Clinical Site2 | Chiba | |
| Japan | Tokyo Clinical Site | Chuo-ku | Tokyo |
| Japan | Tokyo Clinical Site | Fuchu | Tokyo |
| Japan | Fukui Clinical Site | Fukui | |
| Japan | Fukuoka Clinical Site1 | Fukuoka | |
| Japan | Fukuoka Clinical Site2 | Fukuoka | |
| Japan | Fukuoka Clinical Site3 | Fukuoka | |
| Japan | Fukuoka Clinical Site4 | Fukuoka | |
| Japan | Fukushima Clinical Site | Fukushima | |
| Japan | Chiba Clinical Site | Funabashi | Chiba |
| Japan | Gifu Clinical Site | Gifu-shi | Gifu |
| Japan | Hokkaido Clinical Site | Hakodate | Hokkaido |
| Japan | Shizuoka Clinical Site | Hamamatsu-shi | Shizuoka |
| Japan | Saitama Clinical Site | Hidaka | Saitama |
| Japan | Ibaraki Clinical Site | Higashiibaraki-gun | Ibaraki |
| Japan | Aomori Clinical Site | Hirosaki | Aomori |
| Japan | Hiroshima Clinical Site1 | Hiroshima | |
| Japan | Hiroshima Clinical Site2 | Hiroshima | |
| Japan | Hiroshima Clinical Site3 | Hiroshima | |
| Japan | Fukuoka Clinical Site | Iizuka | Fukuoka |
| Japan | Nara Clinical Site | Ikoma | Nara |
| Japan | Kanagawa Clinical Site | Isehara | Kanagawa |
| Japan | Osaka Clinical Site | Izumi | Osaka |
| Japan | Kanagawa Clinical Site | Kamakura | Kanagawa |
| Japan | Chiba Clinical Site | Kamogawa | Chiba |
| Japan | Ishikawa Clinical Site1 | Kanazawa | Ishikawa |
| Japan | Ishikawa Clinical Site2 | Kanazawa | Ishikawa |
| Japan | Nara Clinical Site | Kashihara-shi | Nara |
| Japan | Chiba Clinical Site | Kashiwa | Chiba |
| Japan | Kagawa Clinical Site | Kita-gun | Kagawa |
| Japan | Saitama Clinical Site | Kitaadachi-gun | Saitama |
| Japan | Fukuoka Clinical Site1 | Kitakyushu | Fukuoka |
| Japan | Fukuoka Clinical Site2 | Kitakyushu | Fukuoka |
| Japan | Hyogo Clinical Site | Kobe | Hyogo |
| Japan | Tokyo Clinical Site | Koto-ku | Tokyo |
| Japan | Kumamoto Clinical Site1 | Kumamoto | |
| Japan | Kumamoto Clinical Site2 | Kumamoto | |
| Japan | Kumamoto Clinical Site3 | Kumamoto | |
| Japan | Okayama Clinical Site | Kurashiki | Okayama |
| Japan | Hiroshima Clinical Site | Kure | Hiroshima |
| Japan | Fukuoka Clinical Site | Kurume | Fukuoka |
| Japan | Kyoto Clinical Site1 | Kyoto | |
| Japan | Kyoto Clinical Site2 | Kyoto | |
| Japan | Kyoto Clinical Site3 | Kyoto | |
| Japan | Gumma Clinical Site | Maebashi | Gumma |
| Japan | Ehime Clinical Site1 | Matsuyama | Ehime |
| Japan | Ehime Clinical Site2 | Matsuyama | Ehime |
| Japan | Tokyo Clinical Site | Minato-ku | Tokyo |
| Japan | Aomori Clinical Site | Misawa | Aomori |
| Japan | Iwate Clinical Site | Morioka | Iwate |
| Japan | Aichi Clinical Site | Nagoya | Aichi |
| Japan | Miyagi Clinical Site | Natori | Miyagi |
| Japan | Niigata Clinical Site | Niigata | |
| Japan | Hyogo Clinical Site | Nishinomiya | Hyogo |
| Japan | Gifu Clinical Site | Ogaki | Gifu |
| Japan | Okayama Clinical Site | Okayama | |
| Japan | Osaka Clinical Site1 | Osaka | |
| Japan | Osaka Clinical Site2 | Osaka | |
| Japan | Osaka Clinical Site3 | Osaka | |
| Japan | Osaka Clinical Site4 | Osaka | |
| Japan | Osaka Clinical Site | Osakasayama | Osaka |
| Japan | Miyagi Clinical Site | Osaki | Miyagi |
| Japan | Gunma Clinical Site | Ota | Gunma |
| Japan | Kanagawa Clinical Site | Sagamihara | Kanagawa |
| Japan | Osaka Clinical Site | Sakai | Osaka |
| Japan | Yamagata Clinical Site | Sakata | Yamagata |
| Japan | Nagano Clinical Site | Saku | Nagano |
| Japan | Hokkaido Clinical Site1 | Sapporo | Hokkaido |
| Japan | Hokkaido Clinical Site2 | Sapporo | Hokkaido |
| Japan | Hokkaido Clinical Site3 | Sapporo | Hokkaido |
| Japan | Hokkaido Clinical Site4 | Sapporo-shi | Hokkaido |
| Japan | Miyagi Clinical Site | Sendai-shi | Miyagi |
| Japan | Tochigi Clinical Site | Shimotsuke | Tochigi |
| Japan | Tokyo Clinical Site | Shinagawa-ku | Tokyo |
| Japan | Tokyo Clinical Site1 | Shinjuku-ku | Tokyo |
| Japan | Tokyo Clinical Site2 | Shinjuku-ku | Tokyo |
| Japan | Shizuoka Clinical Site | Shizuoka | |
| Japan | Osaka Clinical Site | Suita | Osaka |
| Japan | Tokyo Clinical Site | Tachikawa | Tokyo |
| Japan | Gumma Clinical Site | Takasaki | Gumma |
| Japan | Osaka Clinical Site | Takatsuki | Osaka |
| Japan | Tokushima Clinical Site | Tokushima | |
| Japan | Toyama Clinical Site | Toyama | |
| Japan | Osaka Clinical Site | Toyonaka | Osaka |
| Japan | Ibaraki Clinical Site | Tsuchiura-shi | Ibaraki |
| Japan | Tochigi Clinical Site | Utsunomiya | Tochigi |
| Japan | Wakayama Clinical Site | Wakayama | |
| Japan | Yamagata Clinical Site | Yamagata | |
| Japan | Kanagawa Clinical Site1 | Yokohama | Kanagawa |
| Japan | Kanagawa Clinical Site2 | Yokohama | Kanagawa |
| Japan | Kanagawa Clinical Site3 | Yokohama | Kanagawa |
| Japan | Tottori Clinical Site | Yonago | Tottori |
| Korea, Republic of | Busan Clinical Site | Busan | |
| Korea, Republic of | Daegu Clinical Site 1 | Daegu | |
| Korea, Republic of | Daegu Clinical Site 2 | Daegu | |
| Korea, Republic of | Daejeon Clinical Site | Daejeon | |
| Korea, Republic of | Gyeonggi-Do Clinical Site1 | Gyeonggi-Do | |
| Korea, Republic of | Gyeonggi-Do Clinical Site2 | Gyeonggi-Do | |
| Korea, Republic of | Gyeonggi-Do Clinical Site3 | Gyeonggi-Do | |
| Korea, Republic of | Gyeonggi-Do Clinical Site4 | Gyeonggi-Do | |
| Korea, Republic of | Gyeonggi-Do Clinical Site5 | Gyeonggi-Do | |
| Korea, Republic of | Gyeongnam Clinical Site | Gyeongnam | |
| Korea, Republic of | Incheon Clinical Site | Incheon | |
| Korea, Republic of | Jeollabuk-Do Clinical Site | Jeollabuk-Do | |
| Korea, Republic of | Jeollanam-do Clinical Site | Jeollanam-do | |
| Korea, Republic of | Seoul Clinical Site 1 | Seoul | |
| Korea, Republic of | Seoul Clinical Site 2 | Seoul | |
| Korea, Republic of | Seoul Clinical Site 3 | Seoul | |
| Korea, Republic of | Seoul Clinical Site 4 | Seoul | |
| Korea, Republic of | Seoul Clinical Site 5 | Seoul | |
| Korea, Republic of | Seoul Clinical Site 6 | Seoul | |
| Korea, Republic of | Seoul Clinical Site7 | Seoul | |
| Korea, Republic of | Seoul Clinical Site8 | Seoul | |
| Korea, Republic of | Seoul Clinical Site9 | Seoul | |
| Korea, Republic of | Ulsan Clinical Site | Ulsan | |
| Taiwan | Kaohsiung Clinical Site1 | Kaohsiung | |
| Taiwan | Kaohsiung Clinical Site2 | Kaohsiung | |
| Taiwan | New Taipei Clinical Site 1 | New Taipei | |
| Taiwan | Taichung Clinical Site 1 | Taichung | |
| Taiwan | Taichung Clinical Site2 | Taichung | |
| Taiwan | Tainan Clinical Site1 | Tainan | |
| Taiwan | Tainan Clinical Site2 | Tainan | |
| Taiwan | Taipei Clinical Site1 | Taipei | |
| Taiwan | Taipei Clinical Site2 | 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 | Progression-free survival (central assessment by IRRC) (only Part 2) | Up to study completion (estimated time frame: 48 months) | ||
| Primary | Overall survival (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Objective response rate (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Progression-free survival (assessment by the site investigator)(only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Duration of response (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Disease control rate (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Time to response (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Best overall response (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Percent change in the sum of diameters of target lesions (only Part 2) | Up to study completion (estimated time frame: 54 months) | ||
| Secondary | Safety will be analyzed through the incidence of adverse events, serious adverse events | Up to 28 days from last dose | ||
| Secondary | Safety will be analyzed through the incidence of laboratory abnormalities | Up to 28 days from last dose |
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