Neoplasm Malignant Clinical Trial
Official title:
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies
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".
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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