進行がん（固形腫瘍）の様々な病型を有するアジア人患者を対象に、BI 891065の単剤投与およびBI 754091との併用投与における様々な用量を試験する研究

基本情報

NCT ID

NCT04138823

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

12

治験依頼者名

Boehringer Ingelheim

概要

The primary objective of this trial is: Part A \- To determine the Maximum tolerated dose (MTD) and/or the recommended dose (RD) of BI 891065 monotherapy for further development in Asian patients with advanced solid tumours Part B \- To determine the MTD and/or the RD of BI 891065 in combination with a fixed dose of BI 754091 at 240 mg for further development in Asian patients with advanced solid tumours The secondary objectives are: Part A \- To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 891065 as monotherapy in Asian patients with advanced solid tumours Part B \- To document the safety and tolerability, and characterise PK of the combination therapy of BI 891065 and BI 754091 in Asian patients with advanced solid tumours

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)