A Phase 2, StrateGIST Legacy Study to Provide Continued Treatment With Velzatinib to Participants With Gastrointestinal Stromal Tumors (GIST) Who Have Completed a Velzatinib Parent Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
研究概览
简要总结
This study aims to evaluate the long-term safety and tolerability of velzatinib (GSK6042981) in adults with GIST who have previously received velzatinib in parent study and continue to benefit from the treatment. Participants will be monitored for side effects and overall health to better understand the effects of long-term treatment and support future care for adults with GIST.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Participant is currently receiving treatment with velzatinib for gastrointestinal stromal tumors in a velzatinib parent study that has fulfilled the requirement for the primary objective.
- Participant is benefiting from treatment with velzatinib as assessed by the investigator.
- Participant can understand the study procedures and will agree to participate in the study by providing written informed consent.
- Participant is willing and able to comply with scheduled visit assessments, treatment plans, and any other study procedures.
- Participant has not developed any condition which would preclude further treatment as per parent study.
- For female participants of childbearing potential, have a negative serum or urine (as required by local regulations) beta - Human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to the first dose of study drug.
- Female participants of childbearing potential, if not postmenopausal or surgically sterile, must agree to abstain from heterosexual intercourse or use a highly effective form of contraception with their sexual partners during the dosing period and for a period of at least 30 days after the end-of-treatment. Male participants with partners of childbearing potential must agree that they will abstain from heterosexual intercourse or use condoms and their partners will use highly effective contraceptive methods during the dosing period until at least 30 days after the last dose of study drug.
排除标准
- Participant has permanently discontinued velzatinib treatment in a velzatinib parent study for any reason.
- Participant has received any other systemic anticancer therapy between last dose on the parent study and entering this study.
- Any laboratory abnormality or clinically significant adverse event that, in the opinion of the investigator, represents a clinically significant risk to the participant if enrolled.
- Participant is pregnant or breastfeeding.
研究组 & 干预措施
Velzatinib
干预措施: Velzatinib (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Up to 224 weeks
Duration of TEAEs and SAEs
时间窗: Up to 224 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
时间窗: Up to 224 weeks
Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation
时间窗: Up to 224 weeks
Number of participants with clinically significant changes in vital signs, laboratory parameters, cardiac function, and Eastern Cooperative Oncology Group (ECOG) performance status changes
时间窗: Up to 224 weeks
次要结局
未报告次要终点
研究者
标识符
- NCT 编号
- NCT07843641
- 其他研究编号
- 310019, 2026-526452-31
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (4年后)
- 研究完成日期
- (4年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Study Sponsor 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