NCT01071915已完成3 期
An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 11
- 主要终点
- Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
研究概览
简要总结
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
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
- •Has given written informed consent before any trial-related activity is performed.
- •Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
- •Is a male patient aged 18 years or older
- •Has a screening serum testosterone level >1.5 ng/mL
- •Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
- •Has a screening PSA value of ≥2 ng/mL
- •Has a life expectancy of at least 12 months
排除标准
- •Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
- •Is currently treated with a 5-α-reductase inhibitor
- •Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- •Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- •Has hypersensitivity towards any component of the investigational medicinal product
- •A marked baseline prolongation of QT/QTcF interval
- •A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
- •Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
- •Has a known or suspect hepatic, symptomatic biliary disease
- •Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
- •Has other clinically significant laboratory abnormalities
- •Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
- •Has a mental incapacity or language barriers precluding adequate understanding or co- operation
- •Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
- •Has previously participated in any degarelix trial
研究组 & 干预措施
Degarelix 240/80 mg
Experimental
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
干预措施: Degarelix 240/80 mg (Drug)
结局指标
主要结局
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
时间窗: Day 28 to Day 196
次要结局
- Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3(At day 3)
- Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28(To Day 28)
- Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196(Day 56 to Day 196)
- Cumulative Probability of no PSA Failure From Day 28 to Day 196(To Day 196)
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables(To Day 196)
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight(To Day 196)
研究者
研究点 (11)
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