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A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib

2026年9月4日 更新者：GlaxoSmithKline

A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)

The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

24

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 日本
      • Fukuoka、日本、812-8582
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Eiji Oki
      • Hokkaido、日本、060-8648
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Yoshito Komatsu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
  • Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
  • Documented mutation status of KIT and/or PDGFRA.
  • Tumor tissue may be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Investigators may consult with the sponsor regarding the enrolment of participants for whom archival tissue is no longer available and who are not eligible to undergo a new biopsy.
  • Is willing to use adequate contraception male and/or female participants.

Exclusion Criteria:

  • Known untreated or active central nervous system metastases.
  • Has significant, uncontrolled, or active cardiovascular disease.
  • Participants with a known allergy or hypersensitivity to any component of velzatinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
  • Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
  • Is pregnant or breastfeeding.
  • Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Velzatinib
药品：Velzatinib
Velzatinib will be administered.
其他名称：
  • 葛兰素史克6042981

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Confirmed objective response rate (ORR)
大体时间：Up to 67 weeks
ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).
Up to 67 weeks

次要结果测量

结果测量
措施说明
大体时间
Duration of response (DOR)
大体时间：Up to 156 weeks
DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented disease progression (PD) or death due to any cause, whichever comes first.
Up to 156 weeks
Disease control rate for minimum 8-week period (DCR8)
大体时间：Up to 156 weeks
DCR8 is defined as the percent of participants reaching confirmed CR or PR, or stable disease (SD) sustained for a minimum period of 8 weeks.
Up to 156 weeks
Progression free survival (PFS)
大体时间：Up to 156 weeks
PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death due to any cause, whichever comes first.
Up to 156 weeks
Overall survival (OS)
大体时间：Up to 156 weeks
OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
Up to 156 weeks
Confirmed ORR
大体时间：Up to 156 weeks
ORR is defined as the percent of participants reaching confirmed CR or PR.
Up to 156 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17)
大体时间：Baseline (Day 1) up to 156 weeks
The EORTC QLQ-F17 is a shorter version of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Scores for each scale are averaged and transformed linearly to a score ranging from 0-100. A high score for functional scales and for Global Health Status/QoL represents better functioning ability or HRQoL.
Baseline (Day 1) up to 156 weeks
Change from baseline in EQ-5D-5L score
大体时间：Baseline (Day 1) up to 156 weeks
The EQ-5D-5L is a validated standardised, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Baseline (Day 1) up to 156 weeks
Plasma concentrations of velzatinib
大体时间：Up to 156 weeks
Up to 156 weeks
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), dose reductions and interruptions and discontinuation of study treatment due to toxicity by severity
大体时间：Up to 156 weeks
Up to 156 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月17日

初级完成 (估计的)

2027年11月29日

研究完成 (估计的)

2029年8月17日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月8日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 309344

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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