Study of ONO-4538 in Gastric Cancer

November 13, 2023 updated by: Ono Pharmaceutical Co. Ltd

ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

680

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Akita, Japan
        • Akita Clinical Site
      • Chiba, Japan
        • Chiba Clinical Site2
      • Chiba, Japan
        • Chiba Clinical Site1
      • Fukui, Japan
        • Fukui Clinical site
      • Fukuoka, Japan
        • Fukuoka Clinical Site2
      • Fukuoka, Japan
        • Fukuoka Clinical Site3
      • Fukuoka, Japan
        • Fukuoka Clinical Site4
      • Fukuoka, Japan
        • Fukuoka Clinical Site1
      • Fukushima, Japan
        • Fukushima Clinical Site
      • Hiroshima, Japan
        • Hiroshima Clinical Site1
      • Hiroshima, Japan
        • Hiroshima Clinical Site2
      • Hiroshima, Japan
        • Hiroshima Clinical Site3
      • Kumamoto, Japan
        • Kumamoto Clinical Site1
      • Kumamoto, Japan
        • Kumamoto Clinical Site2
      • Kumamoto, Japan
        • Kumamoto Clinical Site3
      • Kyoto, Japan
        • Kyoto Clinical Site1
      • Kyoto, Japan
        • Kyoto Clinical Site2
      • Kyoto, Japan
        • Kyoto Clinical Site3
      • Niigata, Japan
        • Niigata Clinical Site
      • Okayama, Japan
        • Okayama Clinical site
      • Osaka, Japan
        • Osaka Clinical Site1
      • Osaka, Japan
        • Osaka Clinical Site2
      • Osaka, Japan
        • Osaka Clinical Site3
      • Osaka, Japan
        • Osaka Clinical Site4
      • Shizuoka, Japan
        • Shizuoka Clinical site
      • Tokushima, Japan
        • Tokushima Clinical Site
      • Toyama, Japan
        • Toyama Clinical Site
      • Wakayama, Japan
        • Wakayama Clinical Site
      • Yamagata, Japan
        • Yamagata Clinical Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Clinical Site
    • Aomori
      • Hirosaki, Aomori, Japan
        • Aomori Clinical Site
      • Misawa, Aomori, Japan
        • Aomori Clinical Site
    • Chiba
      • Funabashi, Chiba, Japan
        • Chiba Clinical Site
      • Kamogawa, Chiba, Japan
        • Chiba Clinical Site
      • Kashiwa, Chiba, Japan
        • Chiba Clinical Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Ehime Clinical Site1
      • Matsuyama, Ehime, Japan
        • Ehime Clinical Site2
    • Fukuoka
      • Iizuka, Fukuoka, Japan
        • Fukuoka Clinical site
      • Kitakyushu, Fukuoka, Japan
        • Fukuoka Clinical Site1
      • Kitakyushu, Fukuoka, Japan
        • Fukuoka Clinical Site2
      • Kurume, Fukuoka, Japan
        • Fukuoka Clinical site
    • Gifu
      • Gifu-shi, Gifu, Japan
        • Gifu Clinical site
      • Ogaki, Gifu, Japan
        • Gifu Clinical site
    • Gumma
      • Maebashi, Gumma, Japan
        • Gumma Clinical Site
      • Takasaki, Gumma, Japan
        • Gumma Clinical Site
    • Gunma
      • Ota, Gunma, Japan
        • Gunma Clinical Site
    • Hiroshima
      • Kure, Hiroshima, Japan
        • Hiroshima Clinical Site
    • Hokkaido
      • Hakodate, Hokkaido, Japan
        • Hokkaido Clinical site
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site2
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site1
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site3
      • Sapporo-shi, Hokkaido, Japan
        • Hokkaido Clinical Site4
    • Hyogo
      • Akashi, Hyogo, Japan
        • Hyogo Clinical Site
      • Amagasaki, Hyogo, Japan
        • Hyogo Clinical Site
      • Kobe, Hyogo, Japan
        • Hyogo Clinical Site
      • Nishinomiya, Hyogo, Japan
        • Hyogo Clinical Site
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan
        • Ibaraki Clinical Site
      • Tsuchiura-shi, Ibaraki, Japan
        • Ibaraki Clinical Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Ishikawa Clinical Site2
      • Kanazawa, Ishikawa, Japan
        • Ishikawa Clinical Site1
    • Iwate
      • Morioka, Iwate, Japan
        • Iwate Clinical Site
    • Kagawa
      • Kita-gun, Kagawa, Japan
        • Kagawa Clinical Site
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Kanagawa Clinical Site
      • Kamakura, Kanagawa, Japan
        • Kanagawa Clinical Site
      • Sagamihara, Kanagawa, Japan
        • Kanagawa Clinical Site
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site2
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site3
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site1
    • Miyagi
      • Natori, Miyagi, Japan
        • Miyagi Clinical Site
      • Osaki, Miyagi, Japan
        • Miyagi Clinical Site
      • Sendai-shi, Miyagi, Japan
        • Miyagi Clinical Site
    • Nagano
      • Saku, Nagano, Japan
        • Nagano Clinical Site
    • Nara
      • Ikoma, Nara, Japan
        • Nara Clinical Site
      • Kashihara-shi, Nara, Japan
        • Nara Clinical Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Okayama Clinical site
    • Osaka
      • Izumi, Osaka, Japan
        • Osaka Clinical site
      • Osakasayama, Osaka, Japan
        • Osaka Clinical site
      • Sakai, Osaka, Japan
        • Osaka Clinical site
      • Suita, Osaka, Japan
        • Osaka Clinical site
      • Takatsuki, Osaka, Japan
        • Osaka Clinical site
      • Toyonaka, Osaka, Japan
        • Osaka Clinical site
    • Saitama
      • Hidaka, Saitama, Japan
        • Saitama Clinical site
      • Kitaadachi-gun, Saitama, Japan
        • Saitama Clinical site
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
        • Shizuoka Clinical site
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Tochigi Clinical site
      • Utsunomiya, Tochigi, Japan
        • Tochigi Clinical site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Chuo-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Fuchu, Tokyo, Japan
        • Tokyo Clinical site
      • Koto-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Minato-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Shinagawa-ku, Tokyo, Japan
        • Tokyo Clinical site
      • Shinjuku-ku, Tokyo, Japan
        • Tokyo Clinical Site1
      • Shinjuku-ku, Tokyo, Japan
        • Tokyo Clinical Site2
      • Tachikawa, Tokyo, Japan
        • Tokyo Clinical site
    • Tottori
      • Yonago, Tottori, Japan
        • Tottori Clinical site
    • Yamagata
      • Sakata, Yamagata, Japan
        • Yamagata Clinical Site
      • Busan, Korea, Republic of
        • Busan Clinical Site
      • Daegu, Korea, Republic of
        • Daegu Clinical Site 1
      • Daegu, Korea, Republic of
        • Daegu Clinical Site 2
      • Daejeon, Korea, Republic of
        • Daejeon Clinical Site
      • Gyeonggi-Do, 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
      • Gyeongnam, Korea, Republic of
        • Gyeongnam Clinical Site
      • Incheon, Korea, Republic of
        • Incheon Clinical Site
      • Jeollabuk-Do, Korea, Republic of
        • Jeollabuk-do Clinical Site
      • Jeollanam-do, Korea, Republic of
        • Jeollanam-do Clinical Site
      • Seoul, Korea, Republic of
        • Seoul Clinical Site7
      • Seoul, 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 Site8
      • Seoul, Korea, Republic of
        • Seoul Clinical Site9
      • Ulsan, Korea, Republic of
        • Ulsan Clinical Site
      • Kaohsiung, Taiwan
        • Kaohsiung Clinical Site2
      • Kaohsiung, Taiwan
        • Kaohsiung Clinical Site1
      • New Taipei, Taiwan
        • New Taipei Clinical Site 1
      • Taichung, Taiwan
        • Taichung Clinical Site 1
      • Taichung, Taiwan
        • Taichung Clinical Site2
      • Tainan, Taiwan
        • Tainan Clinical Site2
      • Tainan, Taiwan
        • Tainan Clinical Site1
      • Taipei, Taiwan
        • Taipei Clinical Site1
      • Taipei, Taiwan
        • Taipei Clinical Site2
      • Taoyuan, Taiwan
        • Taoyuan Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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.

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)
Up to study completion (estimated time frame: 48 months)
Overall survival (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)

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
Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame: Up to 28 days from last dose
Up to 28 days from last dose
Objective response rate (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Progression-free survival (assessment by the site investigator)(only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Duration of response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Disease control rate (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Time to response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Best overall response (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)
Percent change in the sum of diameters of target lesions (only Part 2)
Time Frame: Up to study completion (estimated time frame: 54 months)
Up to study completion (estimated time frame: 54 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

November 17, 2022

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimated)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

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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