A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: Aflibercept (AVE0005); Drug: Docetaxel (XRP6976)

• 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.

Study Timeline

• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-07
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

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
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
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
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