ゲムシタビン併用化学療法に抵抗性を示した切除不能胆道癌（BTC）患者におけるレンバチニブ（E7080）の研究

基本情報

NCT ID

NCT02579616

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

29

治験依頼者名

Eisai Inc.

概要

This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.

対象疾患

介入

依頼者（Sponsor）