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ONO-4538 Phase II Rollover Study (ONO-4538-98)
Sponsor: Ono Pharmaceutical Co. Ltd
Summary
This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.
Official title: A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2020-09-10
Completion Date
2026-12-31
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
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
Locations (38)
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, Taiwan
Tainan Clinical Site2
Tainan, Taiwan
Taipei Clinical Site1
Taipei, Taiwan
Taipei Clinical Site2
Taipei, Taiwan
Taoyuan Clinical Site1
Taoyuan District, Taiwan