A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
- Conditions
- Neoplasm Malignant
- Interventions
- Registration Number
- NCT01148615
- Lead Sponsor
- Sanofi
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aflibercept/ docetaxel Aflibercept (AVE0005) 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 Aflibercept/ docetaxel Docetaxel (XRP6976) 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
- Primary Outcome Measures
Name Time Method Dose-Limiting Toxicity (DLT) 3 weeks (cycle 1)
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Sanofi-Aventis Investigational Site Number 156001
🇨🇳Guangzhou, China
Sanofi-Aventis Investigational Site Number 156001🇨🇳Guangzhou, China