NCT01429064已完成2 期
Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 17
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant 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
- •Written informed consent
- •Successful completion of study protocol 3104001
- •Response or stable disease in study 3104001 at week 12
排除标准
- •New serious concurrent medical condition
- •Not able to swallow the study drug
研究组 & 干预措施
ODM-201
Experimental
干预措施: ODM-201 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose of study treatment up to 4 weeks after last dose of study treatment
Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
次要结局
未报告次要终点
研究者
研究点 (17)
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相似试验
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进行中（未招募）
不适用
SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:EUCTR2010-022802-41-FIOrion Corporation Orion Pharma130
进行中（未招募）
不适用
SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 100000004864EUCTR2010-022802-41-EEOrion Corporation Orion Pharma130
进行中（未招募）
1 期
SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022802-41-GBOrion Corporation Orion Pharma