第I相試験：アジア人固形腫瘍患者におけるSAR125844の用量漸増試験

基本情報

NCT ID

NCT01657214

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

70

治験依頼者名

Sanofi

概要

Primary Objective: In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844. In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients). Secondary Objectives: To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities. To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects. To evaluate other pharmacodynamic biomarkers.

対象疾患

介入

依頼者（Sponsor）