NCT00728533撤回3 期
The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
研究概览
简要总结
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.
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
- •Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- •Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
- •Screening PSA level of =2 ng/mL. ECOG score of =
- •Life expectancy of at least one year.
- •CRITERIA FOR EVALUATION:
- •Primary endpoint:
- •Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day
- •Secondary endpoints:
- •Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day
- •Serum levels of testosterone, LH, FSH, and PSA over time.
- •Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
- •Plasma levels of degarelix over time.
- •Frequency and severity of adverse events.
- •Clinically significant changes in laboratory safety parameters.
- •Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
- Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
- Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
干预措施: Degarelix (Drug)
2
Experimental
- Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
- Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
干预措施: Degarelix (Drug)
结局指标
主要结局
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
时间窗: 3-month
次要结局
- To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.(3-month)
- To evaluate pharmacokinetic response.(3-month)
- To compare safety and tolerability profiles of different degarelix three-month dosing regimens.(3-month)
研究者
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