The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer. Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
IV infusion
Sanofi-Aventis Administrative Office
Tokyo, Japan
Dose-limiting toxicity (DLT) combination with FOLFIRI
Time frame: During the first 2 cycles (4 weeks) of study treatment
physical examination, laboratory safety tests, adverse events
Time frame: up to 60 days after last treatment
Pharmacokinetics
Time frame: up to 90 days after last treatment
Tumor burden, endogenous free VEGF
Time frame: every 3 cycles
Immunogenicity
Time frame: up to 90 days after last treatment
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