IDH1変異を有する進行性固形腫瘍におけるBAY1436032の第I相臨床試験

基本情報

NCT ID

NCT02746081

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

81

治験依頼者名

Bayer

概要

The primary objective of this study is: \- Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors. The secondary objectives of this study are: * Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors. * Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032. * Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.

対象疾患

介入

依頼者（Sponsor）