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

Ono Pharmaceutical Co. Ltd26 sites in 3 countries493 target enrollmentOctober 2014

ConditionsGastric Cancer

InterventionsPlacebo ONO-4538

DrugsONO-4538 Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Gastric Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 493
Locations: 26
Primary Endpoint: Overall survival
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

January 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Placebo Arm

Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Intervention: Placebo

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

Intervention: ONO-4538

Outcomes

Primary Outcomes

Overall survival

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

Secondary Outcomes

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