Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

November 16, 2021 updated by: Ono Pharmaceutical Co. Ltd

ONO-4538 Phase III Study A Multicenter, Double-Blind, 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 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

493

Phase

  • 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

  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Clinical Site
      • Fukuoka, Japan, 811-1395
        • Fukuoka Clinical site
      • Fukuoka, Japan, 812-8582
        • Fukuoka Clinical site
      • Gifu, Japan, 501-1194
        • Gifu Clinical site
      • Hiroshima, Japan, 730-8518
        • Hiroshima Clinical Site
      • Osaka, Japan, 537-8511
        • Osaka Clinical site
      • Shizuoka, Japan, 420-8527
        • Shizuoka Clinical site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Clinical Site
    • Aomori
      • Misawa, Aomori, Japan, 033-0022
        • Aomori Clinical Site
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Ehime Clinical Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido Clinical site
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Clinical Site
      • Kobe, Hyogo, Japan, 650-0047
        • Hyogo Clinical Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Ishikawa Clinical Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Kanagawa Clinical Site
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kanagawa Clinical Site
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Clinical Site
    • Nagano
      • Saku, Nagano, Japan, 385-0051
        • Nagano Clinical Site
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Osaka Clinical site
      • Suita, Osaka, Japan, 565-0871
        • Osaka Clinical site
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Clinical site
    • Saitama
      • Kitaadachi, Saitama, Japan, 362-0806
        • Saitama Clinical site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Clinical site
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Tochigi Clinical site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Clinical site
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Tokyo Clinical site
      • Koto-ku, Tokyo, Japan, 135-8550
        • Tokyo Clinical site
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Tokyo Clinical site
  • Korea, Republic of
      • Busan-si, Korea, Republic of, 602-715
        • Busan-si Clinical Site
      • Daegu, Korea, Republic of, 702-210
        • Daegu Clinical Site
      • Gyeonggi-Do, Korea, Republic of, 410-769
        • Gyeonggi-do Clinical Site
      • Gyeonggi-Do, Korea, Republic of, 463-707
        • Gyeonggi-do Clinical Site
      • Seoul, Korea, Republic of, 110-744
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 120-752
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 135-710
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 135-720
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 136-705
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 137-701
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 138-736
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 152-703
        • Seoul Clinical Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Clinical Site
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Clinical Site
      • Taichung, Taiwan, 40447
        • Taichung Clinical Site
      • Tainan, Taiwan, 704
        • Tainan Clinical Site
      • Taipei, Taiwan, 10002
        • Taipei Clinical Site
      • Taipei, Taiwan, 112
        • Taipei Clinical Site
      • Taipei, Taiwan, 114
        • Taipei Clinical Site
      • Taipei, Taiwan, 116
        • Taipei Clinical Site
      • Taoyuan, Taiwan, 333
        • 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

Genders Eligible for Study

All

Description

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

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 Arm
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
Drug: ONO-4538
Placebo Comparator: Placebo Arm
Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Objective response rate
Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Duration of response
Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
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
Time Frame: Continuously throughout study treatment and up to 28 days from last dose
Continuously throughout study treatment and up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame: Continuously throughout study treatment and up to 28 days from last dose
Continuously throughout study treatment and up to 28 days from last dose

Collaborators and Investigators

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

Sponsor

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.

General Publications

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)

October 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4538-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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