iPSCを用いたALS治療薬の用途変更に関する研究（iDReAM）

基本情報

NCT ID: NCT04744532
ステータス: 不明
試験のフェーズ: 第1/第2相
試験タイプ: 介入
目標被験者数: 49
治験依頼者名: Kyoto University Hospital

概要

This study consists of a phase 1 part and a phase 2 part. Phase 1 part: This is a phase 1, open-label, multicenter, dose escalation study to evaluate the safety and tolerability of bosutinib to determine the maximum tolerated dose(MTD) and a recommended phase 2 dose (RP2D) of bosutinib for treatment of ALS patients. Also, efficacy will be evaluated exploratory. Phase 2 part: This is an open label, multicenter, phase 2 part whose purpose is to evaluate the efficacy exploratorily and the long-term (for 24 weeks) safety of bosutinib for the treatment of ALS patients.