EUCTR2011-004404-37-DE进行中（未招募）1 期
Pazopanib in advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib . A non-comparative phase II multicenter study by the Scandinavian Sarcoma Group - PAGIST
Scandinavian Sarcoma Group0 个研究点目标入组 72 人开始时间: 2012年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) metastatic and/or locally advanced GIST
- •b) measurable disease as defined by RECIST
- •c) progressive disease after both imatinib and sunitinib treatment, and also after nilotinib if this drug ha been given
- •d) no other tyrosin kinase inhibitors given than imatinib, sunitinib, and nilotinib
- •e) age at least 18 years
- •f) WHO performance status 0-2
- •g) resolution of toxic side effects from earlier treatment
- •h) sufficient organ functions as defined in the protocol
- •i) acceptence to use adequate contraception throughout the study period for women with childbearing potential
- •j) written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •a) prior malignancy if claiming active treatment or otherwise is judged to be of significance for the study treatment
- •b) clinically significant gastrointestinal bleeding
- •c) uncontrolled infection of significance
- •d) major surgery or trauma within 28 days priot to the start of study treatment
- •e) active bleeding or bleeding diathesis
- •f) uncontrolled hypertension
- •g) endobronchial lesions or lesions infiltrating major pulmonary vessels
- •h) medical, psychiatric or other condition that could interfere with safety or compliance
- •i) pregnancy or lactation
研究者
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