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オキサリプラチン化学療法で以前に治療を受けた転移性結腸直腸癌患者における、FOLFIRI療法と併用したアフリベルセプトとプラセボの比較試験
基本情報
- NCT ID
- NCT01661270
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 332
- 治験依頼者名
- Sanofi
概要
Primary Objective: To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.
対象疾患
Colorectal Cancer Metastatic
介入
Aflibercept(DRUG)
Placebo(DRUG)