EUCTR2010-022803-24-GB进行中（未招募）1 期
SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH CASTRATE RESISTANT PROSTATE CANCER: OPEN, NON-RANDOMISED, UNCONTROLLED, MULTICENTRE, EXTENSION STUDY TO STUDY 3104001 - Arades-Ext Phase II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
入选标准
- •1.Written informed consent (IC) obtained.
- •2.Patients who successfully completed 12 weeks of treatment according to study protocol 3104001, without any serious drug-related AEs or DLT.
- •3.Patient is expected to benefit from participation in the study in the opinion of the investigator.
- •4.Patients with any response or stable disease in study 3104001 at week 12. 5.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment.
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1.New serious concurrent medical condition or psychiatric illness.
- •2.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures. 3.The patient is not able to swallow the study treatment capsules.
研究者
相似试验
进行中（未招募）
不适用
SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001EUCTR2010-022803-24-FIOrion Corporation Orion Pharma130
进行中（未招募）
不适用
SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001Progressive 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)EUCTR2010-022803-24-CZOrion Corporation Orion Pharma130
进行中（未招募）
不适用
SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 100000004864EUCTR2010-022803-24-EEOrion Corporation Orion Pharma130
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