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临床试验/NCT00417807
NCT00417807已完成1 期

Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

Novartis Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
9
试验地点
2
主要终点
Overall tumor response rates

研究概览

简要总结

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Gleevec/Glivec

Experimental

干预措施: Imatinib mesilate (Drug)

结局指标

主要结局

Overall tumor response rates

时间窗: Assessed every 3 months

An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.

次要结局

  • Explore how Imatinib cooperated with other treatment modatilities(Survival data was collected until death)
  • Safety and tolerability(Safety data collected until patients were no longer in study)
  • Conversion rate to surgical resectability(After best tumor response.)
  • Mutational analysis of molecular targets of imatinib (at any time during the study)(At any time during the study)

研究者

申办方类型
Industry

研究点 (2)

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