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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267343
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: ONO-4538 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Actual Study Start Date : October 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]
  2. Objective response rate [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
  3. Duration of response [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
  4. 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 ]
  5. Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267343


Locations
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Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02267343    
Other Study ID Numbers: ONO-4538-12
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action