A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
研究概览
简要总结
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
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
- •Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
- •Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
- •Karnofsky performance index > 70
- •Expected survival ≥ 9 months
排除标准
- •Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
- •Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
- •Patient at risk of spinal cord compression or ureter obstruction
- •Prior hypophysectomy or adrenalectomy
研究组 & 干预措施
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
干预措施: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) (Drug)
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.
干预措施: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) (Drug)
结局指标
主要结局
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
时间窗: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
次要结局
- Maximum Concentration of Serum Testosterone [Cmax] - Raw Data(1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose)
- Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL(12 weeks)
- Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL(12 weeks)
- Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)(1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose)
- Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)(85, 87, 113, 141 and 169 days post-dose)
- Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data(1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose)