A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 195
- 试验地点
- 36
- 主要终点
- Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29
研究概览
简要总结
The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Triptorelin pamoate 22.5 mg 6-month formulation
All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.
干预措施: Triptorelin pamoate (embonate) salt (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29
时间窗: Day 29
Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level \<50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.
Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24
时间窗: From Week 8 to Week 24
Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive LC-MS/MS method. Maintenance of castration was defined as serum testosterone level \<50 ng/dL or 1.735 nmol/L.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance(From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days)
- Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate(Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169)
- Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate(Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169)
- Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24(Baseline (Day 1), Weeks 12 and 24)
- Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate(Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169)
- Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate(Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169)
- Time to Maximum Observed Plasma Concentration of Testosterone(Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169)
- Maximum Observed Plasma Concentration of Testosterone(Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169)
- Time to Castration of Testosterone(Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169)
- Plasma Concentrations of Triptorelin Pamoate(Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24)
- Serum Concentrations of Testosterone(Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24)