2023-509255-14-01招募中2 期
A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Participants with Advanced Prostate Cancer
Antev Limited, Antev Nordic AB4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年4月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
研究概览
简要总结
To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate defined as the cumulative probability of testosterone suppression to < 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being > 90%
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Teverelix DP single-arm, open-label, multi-centre
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •(1) Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1) (2) Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non- metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy (3) Is treatment naïve for GnRH analogues
排除标准
- •(1) Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: (a) Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range (b) Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range (c) Creatinine twice the ULN range (d) Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5% (e) An estimated glomerular filtration rate (eGFR) < 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit. (2) Has any contraindication to the use of teverelix DP (3) Has a life expectancy of less than 1 year (4) Has T levels <1.5 ng/mL at screening (5) Has a medical history of bilateral orchidectomy
结局指标
主要结局
The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
次要结局
- The sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 0.2 ng/mL (0.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
研究者
Carol Marion MacLean
Scientific
Antev Limited
研究点 (4)
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