Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
59 participants
INTERVENTIONAL
2020-09-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ONO-4538 Monotherapy cohort
480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice
ONO-4538
IV infusion over 30 minutes
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
ONO-4538
IV infusion over 30 minutes
oxaliplatin
IV infusion over 2 hours
S-1
Administered orally twice daily
capecitabine
Administered orally twice daily
bevacizumab
IV infusion over 30 minutes
temozolomide
Administered orally once daily for 5 days every 28 days
Interventions
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ONO-4538
IV infusion over 30 minutes
oxaliplatin
IV infusion over 2 hours
S-1
Administered orally twice daily
capecitabine
Administered orally twice daily
bevacizumab
IV infusion over 30 minutes
temozolomide
Administered orally once daily for 5 days every 28 days
Eligibility Criteria
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Inclusion Criteria
2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit
Exclusion Criteria
2. Participant judged by the investigator to be inappropriate as participants of this study
16 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Chiba Clinical Site1
Kashiwa, Chiba, Japan
Ehime Clinical Site1
Matsuyama, Ehime, Japan
Fukuoka Clinical Site1
Kurume, Fukuoka, Japan
Hokkaido Clinical Site1
Sapporo, Hokkaido, Japan
Hyogo Clinical Site1
Akashi, Hyōgo, Japan
Kanagawa Clinical Site1
Yokohama, Kanagawa, Japan
Oita Clinical Site1
Yufu, Oita Prefecture, Japan
Osaka Clinical Site1
Suita, Osaka, Japan
Osaka Clinical Site3
Takatsuki, Osaka, Japan
Saitama Clinical Site1
Hidaka, Saitama, Japan
Saitama Clinical Site2
Kitaadachi-gun, Saitama, Japan
Tokyo Clinical Site3
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site2
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site1
Koto-ku, Tokyo, Japan
Tokyo Clinical Site4
Shinjuku-ku, Tokyo, Japan
Chiba Clinical Site2
Chiba, , Japan
Fukuoka Clinical Site2
Fukuoka, , Japan
Fukuoka Clinical Site3
Fukuoka, , Japan
Hiroshima Clinical Site1
Hiroshima, , Japan
Kyoto Clinical Site1
Kyoto, , Japan
Okayama Clinical Site1
Okayama, , Japan
Osaka Clinical Site2
Osaka, , Japan
Daegu Clinical Site1
Daegu, , South Korea
Gyeonggi-do Clinical site1
Gyeonggi-do, , South Korea
Incheon Clinical Site1
Incheon, , South Korea
Seoul Clinical Site1
Seoul, , South Korea
Seoul Clinical Site2
Seoul, , South Korea
Seoul Clinical Site3
Seoul, , South Korea
Seoul Clinical Site4
Seoul, , South Korea
Seoul Clinical Site5
Seoul, , South Korea
Seoul Clinical Site6
Seoul, , South Korea
Kaohsiung Clinical Site1
Kaohsiung City, , Taiwan
Kaohsiung Clinical Site2
Kaohsiung City, , Taiwan
Tainan Clinical Site1
Tainan City, , Taiwan
Tainan Clinical Site2
Tainan City, , Taiwan
Taipei Clinical Site1
Taipei, , Taiwan
Taipei Clinical Site2
Taipei, , Taiwan
Taoyuan Clinical Site1
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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jRCT2080225345
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-4538-98
Identifier Type: -
Identifier Source: org_study_id
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