Status:
COMPLETED
Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT02267343
Start Date
October 1 2014
End Date
January 1 2021
Last Update
May 3 2024
Active Locations (49)
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1
Aichi Clinical Site
Nagoya, Aichi-ken, Japan, 464-8681
2
Aomori Clinical Site
Misawa, Aomori, Japan, 033-0022
3
Ehime Clinical Site
Matsuyama, Ehime, Japan, 791-0280
4
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan, 060-8648