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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-5774 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
Secondary Objectives:
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept/ docetaxel | Experimental | Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel. Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 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 |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | 3 weeks (cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities | Up to 30 days after last administration within a maximum follow up of 18 months | |
| Pharmacokinetic parameters of aflibercept | up to last aflibercept administration +90 days |
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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 Investigational Site Number 156001 | Guangzhou | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25531046 | Derived | Huang Y, Zou BY, Zhao LP, Zhao HY, Zhao YY, Xue C, Zhang JW, Xu F, Chen LK, Liu JL, Hu ZH, Wu X, Zhang J, Ma YX, Wei CL, Ma Y, Zhang L. Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors. Future Oncol. 2014 Dec;10(16):2579-91. doi: 10.2217/fon.14.206. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel (XRP6976) | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
|
| Pharmacokinetic parameters of docetaxel | cycle 1 |
| Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | up to a maximum follow-up of 18 months |
| Immunogenicity of Aflibercept | up to last aflibercept administration+90 days |
| Endogenous free VEGF | up to last aflibercept administration+30 days |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |