A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 16
- 主要终点
- Number of Participants With Testosterone <0.5 Nanogram/Milliliter
研究概览
简要总结
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
详细描述
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
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
- •Signed informed consent before any trial related activity
- •Proven prostate cancer with a need for endocrine treatment
- •Testosterone level within the normal range for the age
排除标准
- •Previous or current hormonal treatment of prostate cancer
- •Candidate for prostatectomy or radiotherapy
- •History of severe asthma, anaphylactic reactions or Quincke's Oedema
- •Hypersensitivity towards any component of FE200486
- •Cancer disease within the last ten years except for prostate cancer and some skin cancers
- •Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- •Mental incapacity or language barrier
- •Having received an investigational product within the last 12 weeks preceding the trial
- •Previous participation in this trial
研究组 & 干预措施
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
干预措施: Degarelix (Drug)
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
干预措施: Degarelix (Drug)
Degarelix 80 + 20
Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.
干预措施: Degarelix (Drug)
结局指标
主要结局
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
时间窗: Weeks 1,2,4,8,12,16,20,24
次要结局
- Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24(Weeks 4-24)
- Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen(Six months)
- Number of Participants With Normal Prostate-specific Antigen Levels During the Study(Weeks 12, 24)
- Percentage Change in Vital Signs and Body Weight(Baseline and Six months)
- Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24(Weeks 4-24)
- The Number of Participants With Abnormal Liver Function Tests(Six months)