ISRCTN35418671已完成2 期
A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer
Queen Mary, University of London (UK)0 个研究点目标入组 232 人开始时间: 2010年3月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
研究概览
简要总结
2015 Results article in https://dx.doi.org/10.1002/cam4.432 results 2017 Results article in http://dx.doi.org/10.1200/JCO.2015.66.3468 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed metastatic or locally advanced stage IV transitional cell carcinoma of the urothelium
- •2. Able to commence study drug 3 - 8 weeks after completion of 1st line chemotherapy for metastatic bladder cancer
- •3. HER1 and/or HER 2 positive, confirmed by central lab
- •4. Objective response or stable disease following 4 - 8 cycles of first-line chemotherapy
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
- •6. Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA
- •7. Written informed consent
- •8. Aged over 18 years, either sex
排除标准
- •1. Progression with first-line chemotherapy for metastatic disease
- •2. Previous anti-HER1 or HER2 therapy
- •3. More than one line of chemotherapy for metastatic or locally advanced disease
- •4. Significant cardiac disease
- •5. Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation
- •6. Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed)
研究者
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