骨髄増殖性腫瘍患者におけるナビトクラックス単独療法およびルキソリチニブとの併用療法の安全性、忍容性、および薬物動態を評価する研究

基本情報

NCT ID

NCT04041050

ステータス

実施中（募集終了）

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

85

治験依頼者名

AbbVie

概要

There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)