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

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02267343
Collaborator
(none)
493
Enrollment
49
Locations
2
Arms
75
Actual Duration (Months)
10.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
493 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [Up to study completion (estimated time frame: 30 months), every 2 weeks in principle]

Secondary Outcome Measures

  1. Progression-free survival [Up to study completion (estimated time frame: 30 months), every 2 weeks in principle]

  2. Objective response rate [Up to study completion (estimated time frame: 30 months), every 6 weeks in principle]

  3. Duration of response [Up to study completion (estimated time frame: 30 months), every 6 weeks in principle]

  4. 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]

  5. Safety will be analyzed through the incidence of laboratory abnormalities [Continuously throughout study treatment and up to 28 days from last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aichi Clinical Site Nagoya Aichi 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
5 Hyogo Clinical Site Akashi Hyogo Japan 673-8558
6 Hyogo Clinical Site Kobe Hyogo Japan 650-0047
7 Ishikawa Clinical Site Kanazawa Ishikawa Japan 920-8641
8 Kanagawa Clinical Site Kawasaki Kanagawa Japan 216-8511
9 Kanagawa Clinical Site Sagamihara Kanagawa Japan 252-0375
10 Kanagawa Clinical Site Yokohama Kanagawa Japan 241-8515
11 Nagano Clinical Site Saku Nagano Japan 385-0051
12 Osaka Clinical Site Osakasayama Osaka Japan 589-8511
13 Osaka Clinical Site Suita Osaka Japan 565-0871
14 Osaka Clinical Site Takatsuki Osaka Japan 569-8686
15 Saitama Clinical Site Kitaadachi Saitama Japan 362-0806
16 Shizuoka Clinical Site Sunto-gun Shizuoka Japan 411-8777
17 Tochigi Clinical Site Shimotsuke Tochigi Japan 329-0498
18 Tokyo Clinical Site Bunkyo-ku Tokyo Japan 113-8677
19 Tokyo Clinical Site Chuo-ku Tokyo Japan 104-0045
20 Tokyo Clinical Site Koto-ku Tokyo Japan 135-8550
21 Tokyo Clinical Site Shinjuku-ku Tokyo Japan 160-8582
22 Chiba Clinical Site Chiba Japan 260-8717
23 Fukuoka Clinical Site Fukuoka Japan 811-1395
24 Fukuoka Clinical Site Fukuoka Japan 812-8582
25 Gifu Clinical Site Gifu Japan 501-1194
26 Hiroshima Clinical Site Hiroshima Japan 730-8518
27 Osaka Clinical Site Osaka Japan 537-8511
28 Shizuoka Clinical Site Shizuoka Japan 420-8527
29 Busan-si Clinical Site Busan-si Korea, Republic of 602-715
30 Daegu Clinical Site Daegu Korea, Republic of 702-210
31 Gyeonggi-Do Clinical Site Gyeonggi-Do Korea, Republic of 410-769
32 Gyeonggi-Do Clinical Site Gyeonggi-Do Korea, Republic of 463-707
33 Seoul Clinical Site Seoul Korea, Republic of 110-744
34 Seoul Clinical Site Seoul Korea, Republic of 120-752
35 Seoul Clinical Site Seoul Korea, Republic of 135-710
36 Seoul Clinical Site Seoul Korea, Republic of 135-720
37 Seoul Clinical Site Seoul Korea, Republic of 136-705
38 Seoul Clinical Site Seoul Korea, Republic of 137-701
39 Seoul Clinical Site Seoul Korea, Republic of 138-736
40 Seoul Clinical Site Seoul Korea, Republic of 152-703
41 Kaohsiung Clinical Site Kaohsiung Taiwan 807
42 Kaohsiung Clinical Site Kaohsiung Taiwan 833
43 Taichung Clinical Site Taichung Taiwan 40447
44 Tainan Clinical Site Tainan Taiwan 704
45 Taipei Clinical Site Taipei Taiwan 10002
46 Taipei Clinical Site Taipei Taiwan 112
47 Taipei Clinical Site Taipei Taiwan 114
48 Taipei Clinical Site Taipei Taiwan 116
49 Taoyuan Clinical Site Taoyuan Taiwan 333

Sponsors and Collaborators

  • Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT02267343
Other Study ID Numbers:
  • ONO-4538-12
First Posted:
Oct 17, 2014
Last Update Posted:
Nov 17, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Stomach Neoplasms
Nivolumab

Study Results

No Results Posted as of Nov 17, 2021