NCT02105675已完成2 期
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
SOTIO a.s.0 个研究点目标入组 60 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Survival rate
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men aged ≥ 18 years
- •Histologically confirmed prostate cancer
- •Presence of skeletal metastasis (by CT or PET or MRI)
- •Disease progression documented by increasing PSA or two new lesions
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
排除标准
- •Confirmed brain and/or leptomeningeal metastases
- •Prior chemotherapy for prostate cancer
- •Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
- •Other uncontrolled intercurrent illness
- •Treatment with immunotherapy against PCa
- •Clinically significant cardiovascular disease
- •Active autoimmune disease requiring treatment
研究组 & 干预措施
DCVAC/PCa add on to Standard of Care
Experimental
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
干预措施: Dendritic Cells DCVAC/PCa (Biological)
Standard of Care
Active Comparator
Docetaxel as an Active Comparator
干预措施: Docetaxel (Drug)
结局指标
主要结局
Survival rate
时间窗: 135 weeks
次要结局
- Duration to Prostate Specific Antigen (PSA) Progression(135 weeks)
- Changes in Pain assessed by EORTC QLQ-C30(0, 10, 22, 37, 53, 65 weeks)
- Incidence of Adverse Events(135 weeks)
- Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30(0, 10, 22, 37, 53, 65 weeks)
- Radiographic Progression Free Survival(135 weeks)
研究者
相似试验
终止
2 期
Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian CarcinomaEpithelial Ovarian CarcinomaNCT02107378SOTIO a.s.22
已完成
2 期
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian CarcinomaOvarian NeoplasmsOvarian Cancer (OvCa)Ovarian Epithelial CancerNCT02107950SOTIO a.s.71
已完成
2 期
Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian CarcinomaOvarian NeoplasmsOvarian Epithelial CancerNCT02107937SOTIO a.s.136
已完成
2 期
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate CancerProstate CancerNCT02107391SOTIO a.s.63
已完成
3 期
Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate CancerMetastatic Castration-resistant Prostate CancerNCT02111577SOTIO a.s.1,182