NCT06948955Available不适用
Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 31
研究概览
简要总结
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
研究设计
- 研究类型
- Expanded Access
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
- •Able to provide written informed consent and commit to recommended EAP assessments.
- •≥18 years of age.
- •Able to swallow tablets.
- •Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
- •Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
- •Meet clinically acceptable local laboratory results.
排除标准
- •Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
- •Prior or known intolerance to sunitinib.
- •Patients who have previously participated in a bezuclastinib clinical trial.
- •Patients with persistent > Grade 2 toxicities from prior therapy.
- •Known PDGFR driving mutations or known SDH deficiency.
- •Pregnant or currently breastfeeding.
- •Other protocol-defined criteria apply.
研究者
研究点 (31)
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