NCT00940563已完成2 期
STI571 (Imatinib) in KIT-expressing Gastrointestinal Stromal Tumors (GIST): a Prospective, Open-label, Multicenter Study on Best Clinical Use in the Advanced Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- tumor response /RecIST criteria)
研究概览
简要总结
Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients ≥ 18 years of age.
- •Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
- •Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
- •At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
- •Performance status 0,1, 2 or 3 (ECOG).
- •Adequate end organ function.
- •Adequate bone marrow function.
- •Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
排除标准
- •Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- •Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
- •Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- •Pregnancy, breast-feeding.
- •Severe and/or uncontrolled medical disease.
- •Known brain metastasis.
- •Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- •Known diagnosis of human immunodeficiency virus (HIV) infection.
- •Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
- •Previous radiotherapy to ≥ 25 % of the bone marrow.
- •Major surgery within 2 weeks prior to study entry.
研究组 & 干预措施
Imatinib
Experimental
干预措施: Imatinib (Drug)
结局指标
主要结局
tumor response /RecIST criteria)
时间窗: first 2 months monthly, then every 3 months
次要结局
- SAE and tolerability profile(ongoing basis)
- OS, DFS(12 months)
- effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease.(12 months)
- which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects.(12 months)
研究者
研究点 (1)
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