Primary Objective: To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors. Secondary Objectives: * To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1). * To evaluate the immunogenicity of IV aflibercept.
Total duration of the study per patient is in the range of 17 to 29 weeks. This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Investigational Site Number 156002
Beijing, China
Investigational Site Number 156001
Guangzhou, China
Number of patients with standard safety assessments (adverse events and laboratory tests)
Time frame: Up to last treatment + 30 days
Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
Time frame: Up to last aflibercept administration + 90 days
Anti-tumor activity assessment - overall response rate
Time frame: Up to 17 Weeks
Anti-tumor activity assessment - duration response
Time frame: Up to 17 Weeks
Anti-aflibercept antibody detection
Time frame: Up to last aflibercept administration + 90 days
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