Sanofi-Aventis Investigational Site Number 156001
Guangzhou, 510060, China
NCT Number: NCT01148615
Primary Objective:
* To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.
Secondary Objectives:
* To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel * To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination * To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease * To evaluate the immunogenicity of IV aflibercept * To measure endogenous free Vascular Endothelial Growth Factor (VEGF)
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Guangzhou, 510060, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Time frame: 3 weeks (cycle 1)
Time frame: Up to 30 days after last administration within a maximum follow up of 18 months
Time frame: up to last aflibercept administration +90 days
Time frame: cycle 1
Time frame: up to a maximum follow-up of 18 months
Time frame: up to last aflibercept administration+90 days
Time frame: up to last aflibercept administration+30 days
Sanofi
Industry
A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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