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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT02267343
First received: October 9, 2014
Last updated: November 13, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Gastric Cancer
Drug: ONO-4538
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

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

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 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 ]
  • Duration of response [ Time Frame: 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 ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]

Estimated Enrollment: 480
Study Start Date: October 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02267343

  Show 49 Study Locations
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02267343     History of Changes
Other Study ID Numbers: ONO-4538-12
Study First Received: October 9, 2014
Last Updated: November 13, 2016

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 29, 2017