ALK、ROS1、またはNTRK1-3遺伝子変異を有する進行固形腫瘍患者におけるレポトレクチニブ（TPX-0005）の研究

基本情報

NCT ID

NCT03093116

ステータス

募集中

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

500

治験依頼者名

Turning Point Therapeutics, Inc.

概要

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

対象疾患

介入

依頼者（Sponsor）

実施施設 (8)