CTIS2023-509255-14-01进行中（未招募）1 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 Limited0 个研究点目标入组 44 人开始时间: 2024年2月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
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
研究者
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