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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2080225345 | Registry Identifier | Japan Registry of Clinical Trials |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4538 Monotherapy cohort | Experimental | 480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice |
|
| Combination therapy cohort | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4538 | Drug | IV infusion over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (Aes) | (non) | From Day 1 up to 28 days after the end of the treatment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| North America Clinical Trial Support Desk | Contact | +18665877745(Toll-Free) | clinical_trial@ono-pharma.com | |
| International Clinical Trial Support Desk | Contact | +17162141777(Standard) | clinical_trial@ono-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba Clinical Site1 | Recruiting | Kashiwa | Chiba | Japan | ||
| Ehime Clinical Site1 |
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| oxaliplatin | Drug | IV infusion over 2 hours |
|
| S-1 | Drug | Administered orally twice daily |
|
| capecitabine | Drug | Administered orally twice daily |
|
| bevacizumab | Drug | IV infusion over 30 minutes |
|
| temozolomide | Drug | Administered orally once daily for 5 days every 28 days |
|
| Completed |
| Matsuyama |
| Ehime |
| Japan |
| Fukuoka Clinical Site1 | Recruiting | Kurume | Fukuoka | Japan |
| Hokkaido Clinical Site1 | Recruiting | Sapporo | Hokkaido | Japan |
| Hyogo Clinical Site1 | Recruiting | Akashi | Hyōgo | Japan |
| Kanagawa Clinical Site1 | Recruiting | Yokohama | Kanagawa | Japan |
| Oita Clinical Site1 | Recruiting | Yufu | Oita Prefecture | Japan |
| Osaka Clinical Site1 | Recruiting | Suita | Osaka | Japan |
| Osaka Clinical Site3 | Recruiting | Takatsuki | Osaka | Japan |
| Saitama Clinical Site1 | Recruiting | Hidaka | Saitama | Japan |
| Saitama Clinical Site2 | Recruiting | Kitaadachi-gun | Saitama | Japan |
| Tokyo Clinical Site3 | Recruiting | Bunkyo-ku | Tokyo | Japan |
| Tokyo Clinical Site2 | Recruiting | Chuo-ku | Tokyo | Japan |
| Tokyo Clinical Site1 | Recruiting | Koto-ku | Tokyo | Japan |
| Tokyo Clinical Site4 | Recruiting | Shinjuku-ku | Tokyo | Japan |
| Chiba Clinical Site2 | Recruiting | Chiba | Japan |
| Fukuoka Clinical Site2 | Recruiting | Fukuoka | Japan |
| Fukuoka Clinical Site3 | Recruiting | Fukuoka | Japan |
| Hiroshima Clinical Site1 | Recruiting | Hiroshima | Japan |
| Kyoto Clinical Site1 | Recruiting | Kyoto | Japan |
| Okayama Clinical Site1 | Recruiting | Okayama | Japan |
| Osaka Clinical Site2 | Recruiting | Osaka | Japan |
| Daegu Clinical Site1 | Recruiting | Daegu | South Korea |
| Gyeonggi-do Clinical site1 | Recruiting | Gyeonggi-do | South Korea |
| Incheon Clinical Site1 | Recruiting | Incheon | South Korea |
| Seoul Clinical Site1 | Recruiting | Seoul | South Korea |
| Seoul Clinical Site2 | Completed | Seoul | South Korea |
| Seoul Clinical Site3 | Recruiting | Seoul | South Korea |
| Seoul Clinical Site4 | Recruiting | Seoul | South Korea |
| Seoul Clinical Site5 | Recruiting | Seoul | South Korea |
| Seoul Clinical Site6 | Recruiting | Seoul | South Korea |
| Kaohsiung Clinical Site1 | Completed | Kaohsiung City | Taiwan |
| Kaohsiung Clinical Site2 | Completed | Kaohsiung City | Taiwan |
| Tainan Clinical Site1 | Recruiting | Tainan | Taiwan |
| Tainan Clinical Site2 | Recruiting | Tainan | Taiwan |
| Taipei Clinical Site1 | Recruiting | Taipei | Taiwan |
| Taipei Clinical Site2 | Recruiting | Taipei | Taiwan |
| Taoyuan Clinical Site1 | Recruiting | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
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