Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To assess the efficacy and the safety of imatinib mesylate therapy
研究概览
简要总结
This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.
详细描述
Condition
Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.
Not included:
Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
- •Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
- •Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry.
排除标准
- •Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
- •A primary prostate, breast, lung or brain tumour,
- •Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
- •Other protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
imatinib mesylate (STI571)
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
To assess the efficacy and the safety of imatinib mesylate therapy
时间窗: 2 years
次要结局
- To evaluate the effects of imatinib on quality of life and healthcare resource use(2 years)