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この研究は、様々な種類の進行癌(固形腫瘍)患者におけるBI 907828(ブリギマドリン)の最適な投与量を見つけることを目的としている。

基本情報

NCT ID
NCT03449381
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
266
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

対象疾患

Neoplasms

介入

BI 907828(DRUG)

実施施設 (1)

国立研究開発法人国立がん研究センター中央病院

Tokyo, Chuo-ku, Japan