EUCTR2015-004596-72-IT进行中（未招募）1 期
A phase II study evaluating the efficacy of enzalutamide and the role of ARv7 in metastatic castration resistant prostate cancer (mCRPC) patients with visceral disease - EXCALIBUR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- Male
入选标准
- •- Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma
- •- Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria)
- •- Life expectancy > 3 months
- •- Patients may have received previous therapy including chemotherapy (including docetaxel)
- •- Progressive disease by PSA or imaging in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria (according with PCWG2)
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Metastases in the brain or active epidural disease
- •- History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
- •- Prior treatment with abiraterone acetate
- •- Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride)
研究者
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