NCT01656161已完成3 期
A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer
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
- 120
- 试验地点
- 10
- 主要终点
- Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:
- achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and
- in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Meets protocol-specified criteria for qualification and contraception
- •Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
排除标准
- •Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
研究组 & 干预措施
Triptorelin embonate 22.5 mg
Experimental
Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
干预措施: Triptorelin embonate 22.5 mg (Drug)
结局指标
主要结局
Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
时间窗: within 337 days
次要结局
- Triptorelin PK Metrics for Both Injections: Cmax(Days 1-169 and Days 169-337)
- Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)(Days 1-169)
- Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337(Baseline through Day 337)
- Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)(Days 1-169)
- Testosterone PD Metrics for First Injection: Time to Castration (Tcast)(Days 1-169)
- Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)(Day 171)
- Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)(Days 1-169 and Days 169-337)
- Triptorelin PK Metrics for Both Injections: Concentration 0 Hour(Days 1-169 and Days 169-337)
- Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169(on Days 1 and 169)
- Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)(Days 1-169)
研究者
研究点 (10)
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