An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Change in ECG parameters
研究概览
简要总结
This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.
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. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
- •Has completed the 000006 trial
排除标准
- •Has been withdrawn/discontinued from the 000006 trial.
研究组 & 干预措施
Degarelix
干预措施: Degarelix (Drug)
结局指标
主要结局
Change in ECG parameters
时间窗: Baseline to Month 26
Number and percentage of patients with Adverse Events (AEs)
时间窗: Baseline to Month 26
Change in body weight and vital signs
时间窗: Baseline to Month 26
Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)
时间窗: Baseline to Month 26
次要结局
- Change in testosterone levels(Baseline to Month 26)
- Change in prostate-specific antigen (PSA) levels(Baseline to Month 26)
- Cumulative probability of no PSA failure(Baseline to Month 26)