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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031200286 | Registry Identifier | Japan Registry of Clinical Trials |
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This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4578+ONO-4538+mFFX | Experimental |
| |
| ONO-4578+ONO-4538+GnP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 28 days | |
| Adverse event(AE) | UP to 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Plasma concentration for ONO-4578) | Up to 28 days after the last dose | |
| Pharmacokinetics (Serum concentration for ONO-4538) | Up to 28 days after the last dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | Japan | |||
| Kanagawa Cancer Center |
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| ONO-4538 | Drug | Specified dose on specified days |
|
|
| Oxaliplatin | Drug | Specified dose on specified days |
|
| Levofolinate | Drug | Specified dose on specified days |
|
| Irinotecan | Drug | Specified dose on specified days |
|
| Fluorouracil | Drug | Specified dose on specified days |
|
| Gemcitabine | Drug | Specified dose on specified days |
|
| Nab-Paclitaxel | Drug | Specified dose on specified days |
|
| Overall response rate (ORR) |
| Up to 2 years |
| Disease control rate (DCR) | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
| Progression-free survival (PFS) | Up to 2 years |
| Duration of response (DOR) | Up to 2 years |
| Time to response (TTR) | Up to 2 years |
| Best overall response (BOR) | Up to 2 years |
| Percentage of change in the sum of tumor diameters of target lesions | Up to 2 years |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Up to 2 years |
| Changes in tumor markers (CEA and CA19-9) | Up to 2 years |
| Yokohama |
| Kanagawa |
| Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | Japan |
| Juntendo University Hospital | Bunkyō-Ku | Tokyo | Japan |
| The University of Tokyo Hospital | Bunkyō-Ku | Tokyo | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | Japan |
| The Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo | Japan |
| Kyorin University Hospital | Mitaka-shi | Tokyo | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | Japan |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| 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 |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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