NCT07218926招募中3 期
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 161
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
- •Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
- •Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.
- •Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.
排除标准
- •GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
- •Known untreated or active central nervous system metastases.
- •Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. 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.
研究组 & 干预措施
Sunitinib
Active Comparator
干预措施: Sunitinib (Drug)
IDRX-42 (GSK6042981)
Experimental
干预措施: IDRX-42 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 130 weeks
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to approximately 261 weeks)
- Plasma concentrations of IDRX-42 (GSK6042981)(Up to approximately 261 weeks)
- Overall Survival (OS)(Up to approximately 261 weeks)
- Progression-Free Survival (PFS)(Up to approximately 261 weeks)
- Confirmed Overall Objective Response Rate (ORR)(Up to approximately 261 weeks)
- Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)(Up to approximately 261 weeks)
- Time to Response (TTR)(Up to approximately 261 weeks)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)(Baseline (Day 1) and up to approximately 261 weeks)
- Time To Confirmed Deterioration (TTCD)(Up to approximately 261 weeks)
- Number of Participants with TEAEs and SAEs by severity(Up to approximately 261 weeks)
- Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity(Up to approximately 261 weeks)
- Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to approximately 261 weeks)
- Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)(Up to approximately 261 weeks)
研究者
研究点 (161)
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