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

Sponsor
Sanofi
Study ID
NCT01148615
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasm Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (AVE0005) — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous
  • Docetaxel (XRP6976) — DRUG
    Pharmaceutical form: solution for infusion Route of administration: intravenous

Study Details

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)

Key Dates

Start date
Jul 31, 2010
Status verified
Jan 2012
Primary completion
Sep 30, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept/ docetaxel
    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 Measure

Dose-Limiting Toxicity (DLT) [ Time Frame: 3 weeks (cycle 1) ]

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