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To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-7913+ONO-4538+mFFX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7913 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 28 days | |
| Adverse event(AE) | UP to 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics（serum concentration of ONO-7913） | Through study completion, an average of 6 months | |
| Pharmacokinetics（serum concentration of ONO-4538） | Through study completion, an average of 6 months |
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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 |
|
| Overall response rate (ORR) | Through study completion, an average of 6 months |
| Disease control rate (DCR) | Through study completion, an average of 6 months |
| Overall survival (OS) | Through study completion, an average of 6 months |
| Progression-free survival (PFS) | Through study completion, an average of 6 months |
| Duration of response (DOR) | Through study completion, an average of 6 months |
| Time to response (TTR) | Through study completion, an average of 6 months |
| Best overall response (BOR) | Through study completion, an average of 6 months |
| Percentage of change in the sum of tumor diameters of target lesions | Through study completion, an average of 6 months |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Through study completion, an average of 6 months |
| Changes in tumor markers (CEA and CA19-9) | Through study completion, an average of 6 months |
| 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 |
| The Cancer Institute Hospital ofJFCR | Koto-ku | Tokyo | Japan |
| Kyorin University Hospital | Mitaka-shi | Tokyo | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | Japan |
| National Cancer Center Hospital | Chūōku | 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 |
|---|---|
| C000629291 | magrolimab |
| D000077594 | Nivolumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| 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 |
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