進行胃腸癌患者におけるBI 905711の安全かつ効果的な投与量を見つけるための研究

基本情報

NCT ID

NCT04137289

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

110

治験依頼者名

Boehringer Ingelheim

概要

Phase 1a - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase 1a - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase 1b - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)