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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-7286 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.
Secondary Objectives:
Total duration of the study per patient is in the range of 17 to 29 weeks.
This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept AVE0005 | Drug | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with standard safety assessments (adverse events and laboratory tests) | Up to last treatment + 30 days | |
| Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU) | Up to last aflibercept administration + 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor activity assessment - overall response rate | Up to 17 Weeks | |
| Anti-tumor activity assessment - duration response | Up to 17 Weeks | |
| Anti-aflibercept antibody detection |
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Inclusion criteria:
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate
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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 156002 | Beijing | 100071 | China | |||
| Investigational Site Number 156001 |
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| Leucovorin | Drug | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
|
| Irinotecan | Drug | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
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| 5-Fluorouracil | Drug | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
|
| Up to last aflibercept administration + 90 days |
| Guangzhou |
| 510060 |
| China |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| 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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