An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 30
- 主要终点
- Time From Dosing Until Testosterone Levels >0.5 ng/mL
研究概览
简要总结
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.
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
- •Written informed consent obtained before any trial related procedures
- •Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
- •ECOG score to be equal to or above 2
- •Testosterone level within age-specific normal range
- •PSA value equal to or above 2 ng/ml
- •Life expectancy of at least 6 months
排除标准
- •Previous or current hormonal treatment of prostate cancer
- •Recent or current treatment with any drugs modifying the testosterone level
- •Candidate for curative treatment such as 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
- •Signs of liver impairment shown as elevated serum ALT or serum bilirubin
- •Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
- •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 120 mg (20 mg/mL)
Degarelix 120 mg (20 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (40 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 120 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 160 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 200 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 200 mg (60 mg/mL)
Degarelix 200 mg (60 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 240 mg (60 mg/mL)
Degarelix 240 mg (60 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 320 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)
干预措施: Degarelix (Drug)
结局指标
主要结局
Time From Dosing Until Testosterone Levels >0.5 ng/mL
时间窗: 3 months
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards.
次要结局
- Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days(Two - six months)
- Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days(3 months)
- Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)(3 months)
- Time to 50% Reduction in Prostate-specific Antigen Levels(3 months)
- Time to 90% Reduction in Prostate-specific Antigen Levels(3 months)
- Evaluation of Liver Function Tests(3 months)
- Participants With Markedly Abnormal Change in Vital Signs and Body Weight(3 months)