Gastric Cancer
Conditions
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.
Interventions
DRUGONO-4538
DRUGPlacebo
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of response | 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 |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed