進行乳がんを有する日本人閉経後患者における経口投与アムセネストラント（SAR439859）の評価（AMEERA-2）

基本情報

NCT ID

NCT03816839

ステータス

中止

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

10

治験依頼者名

Sanofi

概要

Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer. Secondary Objective: * To characterize the overall safety profile of SAR439859 administered as monotherapy. * To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. * To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

対象疾患

介入

依頼者（Sponsor）