A Single Stage Phase II, Multi-centre, Open Label Study of Imatinib in Combination With Pioglitazone, Etoricoxib, Dexamethasone and Low-dose Treosulfane for Anti-inflammatory and Angiostatic Treatment in Patients With Hormone-refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- PSA Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, tolerability and safety of a multi-targeted therapy in patients with hormone-refractory prostate cancer.
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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
干预措施: imatinib mesylate (Drug)
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
干预措施: Treosulfane (Drug)
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
干预措施: etoricoxib (Drug)
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
干预措施: pioglitazone (Drug)
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
干预措施: dexamethasone (Drug)
结局指标
主要结局
PSA Response Rate
时间窗: up to 24 weeks
To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.
次要结局
- Overall Survival Rate(every 4 weeks up to 24 weeks)
- Quality of Life Assessed With EORTC-30(baseline and Final Visit (week 24))
- Time to PSA Response(every 4 weeks up to 24 weeks)
- Time to Progression-free Survival(every 4 weeks up to 24 weeks)