NCT01261572已完成2 期
ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
研究概览
简要总结
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
详细描述
ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate cancer (adenocarcinoma) of all stages
- •A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention
- •Serum testosterone level above 2.2 ng/mL
- •An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
- •Serum PSA level above 2 ng/mL
排除标准
- •Previous or present endocrine treatment for prostate cancer.
- •However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months
- •Treated with a 5α-reductase inhibitor
- •A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- •Concurrent or a history of severe liver disease
- •Abnormal ECG such as long QTc
- •A patient receiving ASP3550 in past times
- •Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study
研究组 & 干预措施
High dose group
Experimental
ASP3350 high dose
干预措施: degarelix (Drug)
Low dose group
Experimental
ASP3350 low dose
干预措施: degarelix (Drug)
结局指标
主要结局
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
时间窗: Baseline and for one year
次要结局
- Time to the recurrence of serum PSA(For one year)
- Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests(One year)
- Changes in serum level of testosterone over time(Baseline and for one year)
- Changes in serum level of Luteinizing Hormone (LH) over time(Baseline and for one year)
- Changes in serum level of Follicle Stimulating Hormone (FSH) over time(Baseline and for one year)
- Changes in serum level of Prostate Specific Antigen (PSA) over time(Baseline and for one year)
研究者
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