Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: ONO-4538 Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Locations
Aichi Clinical Site
Nagoya, Aichi, Japan
Status: Recruiting
Aomori Clinical Site
Misawa, Aomori, Japan
Status: Recruiting
Chiba Clinical Site
Kashiwa, Chiba, Japan
Status: Recruiting
Ehime Clinical Site
Matsuyama, Ehime, Japan
Status: Recruiting
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan
Status: Recruiting
Hyogo Clinical Site
Akashi, Hyogo, Japan
Status: Recruiting
Hyogo Clinical Site
Kobe, Hyogo, Japan
Status: Recruiting
Kanagawa Clinical Site
Kawasaki, Kanagawa, Japan
Status: Recruiting
Kanagawa Clinical Site
Sagamihara, Kanagawa, Japan
Status: Recruiting
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
Status: Recruiting
Osaka Clinical Site
Osakasayama, Osaka, Japan
Status: Recruiting
Osaka Clinical Site
Suita, Osaka, Japan
Status: Recruiting
Osaka Clinical Site
Takatsuki, Osaka, Japan
Status: Recruiting
Saitama Clinical Site
Kitaadachi, Saitama, Japan
Status: Recruiting
Shizuoka Clinical Site
Sunto-gun, Shizuoka, Japan
Status: Recruiting
Tochigi Clinical Site
Shimotsuke, Tochigi, Japan
Status: Recruiting
Tokyo Clinical Site
Bunkyo-ku, Tokyo, Japan
Status: Recruiting
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Status: Recruiting
Tokyo Clinical Site
Koto-ku, Tokyo, Japan
Status: Recruiting
Tokyo Clinical Site
Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Chiba Clinical Site
Chiba, Japan
Status: Recruiting
Fukuoka Clinical Site
Fukuoka, Japan
Status: Recruiting
Fukuoka Clinical Site
Fukuoka, Japan
Status: Recruiting
Gifu Clinical Site
Gifu, Japan
Status: Recruiting
Hiroshima Clinical Site
Hiroshima, Japan
Status: Recruiting
Osaka Clinical Site
Osaka, Japan
Status: Recruiting
Busan-si Clinical Site
Busan-si, Korea, Republic of
Status: Recruiting
Daegu Clinical Site
Daegu, Korea, Republic of
Status: Recruiting
Gyeonggi-Do Clinical Site
Gyeonggi-Do, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Seoul Clinical Site
Seoul, Korea, Republic of
Status: Recruiting
Kaohsiung Clinical Site
Kaohsiung, Taiwan
Status: Recruiting
Kaohsiung Clinical Site
Kaohsiung, Taiwan
Status: Recruiting
Taichung Clinical Site
Taichung, Taiwan
Status: Recruiting
Tainan Clinical Site
Tainan, Taiwan
Status: Recruiting
Taipei Clinical Site
Taipei, Taiwan
Status: Recruiting
Taipei Clinical Site
Taipei, Taiwan
Status: Recruiting
Taipei Clinical Site
Taipei, Taiwan
Status: Recruiting
Taipei Clinical Site
Taipei, Taiwan
Status: Recruiting
Taoyuan Clinical Site
Taoyuan, Taiwan
Status: Recruiting
Start Date
October 2014
Sponsors
Ono Pharmaceutical Co. Ltd
Source
Ono Pharmaceutical Co. Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page