The Possible Role of Glivec in Patients With Tumor Cells Positive for C-kit or Platelet Derived Growth Factor Receptor (PDGFR); a Multi Center Study.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate activity of Glivec in escalating doses 400 up to 800mg/day in patients with a large variety of metastatic solid tumors expressing c-kit or PDGFR.
研究概览
简要总结
This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.
Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
- •At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
- •Female patients of child-bearing potential must have negative pregnancy test.
- •Signed informed consent form.
- •Life expectancy >3 months.
排除标准
- •Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
- •Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
- •Patient has a known brain metastases.
- •Patient previously received radiotherapy to >25% of the bone marrow.
结局指标
主要结局
Evaluate activity of Glivec in escalating doses 400 up to 800mg/day in patients with a large variety of metastatic solid tumors expressing c-kit or PDGFR.
次要结局
- Evaluate the toxicity of Glivec in patients with solid tumors.