Study of ONO-4538 in Gastric Cancer

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02746796

Collaborator

(none)

680

Enrollment

130

Locations

Arms

Anticipated Duration (Months)

5.2

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 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: ONO-4538 Drug: Oxaliplatin Drug: Tegafur- Gimeracil-Oteracil potassium Drug: Capecitabine Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

680 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ONO-4538 + SOX Therapy Cohort (Part 1) ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (BSA) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.	Drug: ONO-4538 Drug: Oxaliplatin Drug: Tegafur- Gimeracil-Oteracil potassium
Experimental: ONO-4538 + CapeOX Therapy Cohort (Part 1) ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1200 - 2100 mg bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.	Drug: ONO-4538 Drug: Oxaliplatin Drug: Capecitabine
Experimental: ONO-4538 + chemotherapy group (Part 2) With regard to the ONO-4538 + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.	Drug: ONO-4538 Drug: Oxaliplatin Drug: Tegafur- Gimeracil-Oteracil potassium Drug: Capecitabine
Placebo Comparator: Placebo + Chemotherapy group (Part 2) With regard to the placebo + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. Placebo solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.	Drug: Oxaliplatin Drug: Tegafur- Gimeracil-Oteracil potassium Drug: Capecitabine Drug: Placebo

Outcome Measures

Primary Outcome Measures

Progression-free survival (central assessment by IRRC) (only Part 2) [Up to study completion (estimated time frame: 48 months)]
Overall survival (only Part 2) [Up to study completion (estimated time frame: 54 months)]

Secondary Outcome Measures

Objective response rate (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Progression-free survival (assessment by the site investigator)(only Part 2) [Up to study completion (estimated time frame: 54 months)]
Duration of response (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Disease control rate (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Time to response (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Best overall response (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Percent change in the sum of diameters of target lesions (only Part 2) [Up to study completion (estimated time frame: 54 months)]
Safety will be analyzed through the incidence of adverse events, serious adverse events [Up to 28 days from last dose]
Safety will be analyzed through the incidence of laboratory abnormalities [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:

Inclusion Criteria:

Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
Have measurable lesions as defined in RECIST Guideline Version 1.1
ECOG PS score 0 or 1
Have a life expectancy of at least 3 months

Exclusion Criteria:

Have multiple cancers
Have a current or past history of severe hypersensitivity to any other antibody products
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
1	Aichi Clinical Site	Nagoya	Aichi	Japan
2	Aomori Clinical Site	Hirosaki	Aomori	Japan
3	Aomori Clinical Site	Misawa	Aomori	Japan
4	Chiba Clinical Site	Funabashi	Chiba	Japan
5	Chiba Clinical Site	Kamogawa	Chiba	Japan
6	Chiba Clinical Site	Kashiwa	Chiba	Japan
7	Ehime Clinical Site1	Matsuyama	Ehime	Japan
8	Ehime Clinical Site2	Matsuyama	Ehime	Japan
9	Fukuoka Clinical Site	Iizuka	Fukuoka	Japan
10	Fukuoka Clinical Site1	Kitakyushu	Fukuoka	Japan
11	Fukuoka Clinical Site2	Kitakyushu	Fukuoka	Japan
12	Fukuoka Clinical Site	Kurume	Fukuoka	Japan
13	Gifu Clinical Site	Gifu-shi	Gifu	Japan
14	Gifu Clinical Site	Ogaki	Gifu	Japan
15	Gumma Clinical Site	Maebashi	Gumma	Japan
16	Gumma Clinical Site	Takasaki	Gumma	Japan
17	Gunma Clinical Site	Ota	Gunma	Japan
18	Hiroshima Clinical Site	Kure	Hiroshima	Japan
19	Hokkaido Clinical Site	Hakodate	Hokkaido	Japan
20	Hokkaido Clinical Site4	Sapporo-shi	Hokkaido	Japan
21	Hokkaido Clinical Site1	Sapporo	Hokkaido	Japan
22	Hokkaido Clinical Site2	Sapporo	Hokkaido	Japan
23	Hokkaido Clinical Site3	Sapporo	Hokkaido	Japan
24	Hyogo Clinical Site	Akashi	Hyogo	Japan
25	Hyogo Clinical Site	Amagasaki	Hyogo	Japan
26	Hyogo Clinical Site	Kobe	Hyogo	Japan
27	Hyogo Clinical Site	Nishinomiya	Hyogo	Japan
28	Ibaraki Clinical Site	Higashiibaraki-gun	Ibaraki	Japan
29	Ibaraki Clinical Site	Tsuchiura-shi	Ibaraki	Japan
30	Ishikawa Clinical Site1	Kanazawa	Ishikawa	Japan
31	Ishikawa Clinical Site2	Kanazawa	Ishikawa	Japan
32	Iwate Clinical Site	Morioka	Iwate	Japan
33	Kagawa Clinical Site	Kita-gun	Kagawa	Japan
34	Kanagawa Clinical Site	Isehara	Kanagawa	Japan
35	Kanagawa Clinical Site	Kamakura	Kanagawa	Japan
36	Kanagawa Clinical Site	Sagamihara	Kanagawa	Japan
37	Kanagawa Clinical Site1	Yokohama	Kanagawa	Japan
38	Kanagawa Clinical Site2	Yokohama	Kanagawa	Japan
39	Kanagawa Clinical Site3	Yokohama	Kanagawa	Japan
40	Miyagi Clinical Site	Natori	Miyagi	Japan
41	Miyagi Clinical Site	Osaki	Miyagi	Japan
42	Miyagi Clinical Site	Sendai-shi	Miyagi	Japan
43	Nagano Clinical Site	Saku	Nagano	Japan
44	Nara Clinical Site	Ikoma	Nara	Japan
45	Nara Clinical Site	Kashihara-shi	Nara	Japan
46	Okayama Clinical Site	Kurashiki	Okayama	Japan
47	Osaka Clinical Site	Izumi	Osaka	Japan
48	Osaka Clinical Site	Osakasayama	Osaka	Japan
49	Osaka Clinical Site	Sakai	Osaka	Japan
50	Osaka Clinical Site	Suita	Osaka	Japan
51	Osaka Clinical Site	Takatsuki	Osaka	Japan
52	Osaka Clinical Site	Toyonaka	Osaka	Japan
53	Saitama Clinical Site	Hidaka	Saitama	Japan
54	Saitama Clinical Site	Kitaadachi-gun	Saitama	Japan
55	Shizuoka Clinical Site	Hamamatsu-shi	Shizuoka	Japan
56	Tochigi Clinical Site	Shimotsuke	Tochigi	Japan
57	Tochigi Clinical Site	Utsunomiya	Tochigi	Japan
58	Tokyo Clinical Site	Bunkyo-ku	Tokyo	Japan
59	Tokyo Clinical Site	Chuo-ku	Tokyo	Japan
60	Tokyo Clinical Site	Fuchu	Tokyo	Japan
61	Tokyo Clinical Site	Koto-ku	Tokyo	Japan
62	Tokyo Clinical Site	Minato-ku	Tokyo	Japan
63	Tokyo Clinical Site	Shinagawa-ku	Tokyo	Japan
64	Tokyo Clinical Site1	Shinjuku-ku	Tokyo	Japan
65	Tokyo Clinical Site2	Shinjuku-ku	Tokyo	Japan
66	Tokyo Clinical Site	Tachikawa	Tokyo	Japan
67	Tottori Clinical Site	Yonago	Tottori	Japan
68	Yamagata Clinical Site	Sakata	Yamagata	Japan
69	Akita Clinical Site	Akita		Japan
70	Chiba Clinical Site1	Chiba		Japan
71	Chiba Clinical Site2	Chiba		Japan
72	Fukui Clinical Site	Fukui		Japan
73	Fukuoka Clinical Site1	Fukuoka		Japan
74	Fukuoka Clinical Site2	Fukuoka		Japan
75	Fukuoka Clinical Site3	Fukuoka		Japan
76	Fukuoka Clinical Site4	Fukuoka		Japan
77	Fukushima Clinical Site	Fukushima		Japan
78	Hiroshima Clinical Site1	Hiroshima		Japan
79	Hiroshima Clinical Site2	Hiroshima		Japan
80	Hiroshima Clinical Site3	Hiroshima		Japan
81	Kumamoto Clinical Site1	Kumamoto		Japan
82	Kumamoto Clinical Site2	Kumamoto		Japan
83	Kumamoto Clinical Site3	Kumamoto		Japan
84	Kyoto Clinical Site1	Kyoto		Japan
85	Kyoto Clinical Site2	Kyoto		Japan
86	Kyoto Clinical Site3	Kyoto		Japan
87	Niigata Clinical Site	Niigata		Japan
88	Okayama Clinical Site	Okayama		Japan
89	Osaka Clinical Site1	Osaka		Japan
90	Osaka Clinical Site2	Osaka		Japan
91	Osaka Clinical Site3	Osaka		Japan
92	Osaka Clinical Site4	Osaka		Japan
93	Shizuoka Clinical Site	Shizuoka		Japan
94	Tokushima Clinical Site	Tokushima		Japan
95	Toyama Clinical Site	Toyama		Japan
96	Wakayama Clinical Site	Wakayama		Japan
97	Yamagata Clinical Site	Yamagata		Japan
98	Busan Clinical Site	Busan		Korea, Republic of
99	Daegu Clinical Site 1	Daegu		Korea, Republic of
100	Daegu Clinical Site 2	Daegu		Korea, Republic of
101	Daejeon Clinical Site	Daejeon		Korea, Republic of
102	Gyeonggi-Do Clinical Site1	Gyeonggi-Do		Korea, Republic of
103	Gyeonggi-Do Clinical Site2	Gyeonggi-Do		Korea, Republic of
104	Gyeonggi-Do Clinical Site3	Gyeonggi-Do		Korea, Republic of
105	Gyeonggi-Do Clinical Site4	Gyeonggi-Do		Korea, Republic of
106	Gyeonggi-Do Clinical Site5	Gyeonggi-Do		Korea, Republic of
107	Gyeongnam Clinical Site	Gyeongnam		Korea, Republic of
108	Incheon Clinical Site	Incheon		Korea, Republic of
109	Jeollabuk-Do Clinical Site	Jeollabuk-Do		Korea, Republic of
110	Jeollanam-do Clinical Site	Jeollanam-do		Korea, Republic of
111	Seoul Clinical Site 1	Seoul		Korea, Republic of
112	Seoul Clinical Site 2	Seoul		Korea, Republic of
113	Seoul Clinical Site 3	Seoul		Korea, Republic of
114	Seoul Clinical Site 4	Seoul		Korea, Republic of
115	Seoul Clinical Site 5	Seoul		Korea, Republic of
116	Seoul Clinical Site 6	Seoul		Korea, Republic of
117	Seoul Clinical Site7	Seoul		Korea, Republic of
118	Seoul Clinical Site8	Seoul		Korea, Republic of
119	Seoul Clinical Site9	Seoul		Korea, Republic of
120	Ulsan Clinical Site	Ulsan		Korea, Republic of
121	Kaohsiung Clinical Site1	Kaohsiung		Taiwan
122	Kaohsiung Clinical Site2	Kaohsiung		Taiwan
123	New Taipei Clinical Site 1	New Taipei		Taiwan
124	Taichung Clinical Site 1	Taichung		Taiwan
125	Taichung Clinical Site2	Taichung		Taiwan
126	Tainan Clinical Site1	Tainan		Taiwan
127	Tainan Clinical Site2	Tainan		Taiwan
128	Taipei Clinical Site1	Taipei		Taiwan
129	Taipei Clinical Site2	Taipei		Taiwan
130	Taoyuan Clinical Site	Taoyuan		Taiwan

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:

NCT02746796

Other Study ID Numbers:

ONO-4538-37

First Posted:

Apr 21, 2016

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022