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| Name | Class |
|---|---|
| Yakult Honsha Co., LTD | INDUSTRY |
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This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step 1 | Experimental |
| |
| Step 2 | Experimental |
| |
| Step 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) | event driven | |
| Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) | throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| time to progression | event driven | |
| overall survival | event driven | |
| time to response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Hayashi | Clinical Development Department 3, Group 6 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido Region | Hokkaido | Hokkaido | Japan | |||
| Kanto Region |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Oxaliplatin |
| Drug |
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks) |
|
| Capecitabine | Drug | 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks) |
|
| event driven |
| duration of response | event driven |
| concentrations of R340 and its metabolites | throughout study |
| concentrations of platinum | throughout study |
| concentrations of bevacizumab | throughout study |
| concentrations of vascular endothelial growth factor (VEGF) | throughout study |
| concentrations of anti-bevacizumab antibody | throughout study |
| Kanto |
| Kanto |
| Japan |
| Kinki Region | Kinki | Kinki | Japan |
| Tokai Region | Tōkai | Tokai | Japan |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 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 |