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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer.
Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVE0005 (aflibercept) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVE0005 (aflibercept) | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) combination with FOLFIRI | During the first 2 cycles (4 weeks) of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| physical examination, laboratory safety tests, adverse events | up to 60 days after last treatment | |
| Pharmacokinetics | up to 90 days after last treatment | |
| Tumor burden, endogenous free VEGF |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23179335 | Derived | Yoshino T, Yamazaki K, Yamaguchi K, Doi T, Boku N, Machida N, Onozawa Y, Asayama M, Fujino T, Ohtsu A. A phase I study of intravenous aflibercept with FOLFIRI in Japanese patients with previously treated metastatic colorectal cancer. Invest New Drugs. 2013 Aug;31(4):910-7. doi: 10.1007/s10637-012-9895-6. Epub 2012 Nov 20. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| every 3 cycles |
| Immunogenicity | up to 90 days after last treatment |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |