NCT00568516已完成2 期
Phase II Study of ASP3550 - A Maintenance-dose Finding Study 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
- 273
- 主要终点
- Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
研究概览
简要总结
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
详细描述
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was 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
- •Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
- •Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
- •Has a serum testosterone level above 1.5 ng/mL at screening
- •Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
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 preceding Screening Visit may be included
- •Is being treated with a 5α-reductase inhibitor
- •Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- •Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
研究组 & 干预措施
2.High dose group
Experimental
干预措施: ASP3550 (Drug)
1.Low dose group
Experimental
干预措施: ASP3550 (Drug)
结局指标
主要结局
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
时间窗: 1 Year
次要结局
- Changes in serum levels of testosterone, LH, FSH and PSA over time(1 Year)
- Proportion of patients with testosterone surge(1 Year)
- Time to the recurrence of serum PSA(1 Year)
- Percentage change in serum PSA(1 Year)
研究者
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