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Completed

NCT Number: NCT02267343

Study of ONO-4538 in 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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Clinical Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Drug

Placebo

Drug

Primary outcomes

  1. Overall survival

    Time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2021
First posted
Oct 17, 2014
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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