EUCTR2014-002987-34-DE进行中(未招募)不适用
A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally SymptomaticPharmacogenetics Blood Sample Amendment Number 01
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 250
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
- •- Prostate cancer with metastases
- •- Prostate cancer should be castration resistant
- •- Progression during hormonal therapy
- •Please see protocol for further information on inclusion criteria
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •- Visceral metastases (eg liver, lung or brain metastases)
- •- Prior treatment with any immunotherapy for prostate cancer
- •- Prior or ongoing cytotoxic therapy for prostate cancer
- •- Autoimmune disease
- •- Inadequate hematologic, renal, or hepatic function
- •Please see protocol for further information on exclusion criteria
研究者
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