EUCTR2019-000593-32-DE进行中（未招募）1 期
Phase III, open-label, multi-center study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 10.8 mg goserelin subcutaneous implant (Novalon) in male subjects with prostate cancer.
ovalon S.A.0 个研究点目标入组 142 人开始时间: 2019年3月28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
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Males aged 18 years (inclusive) or above
- •2.Histologically confirmed prostate adenocarcinoma and indicated for ADT. This includes but is not limited to subjects suffering from Localized intermediate-risk or high-risk Prostate Cancer (having a clinical state of T2b and =T2c) and subjects with Locally Advanced Prostate Cancer (having T3-4 as clinical state) [Mottet, 2018; NICE Guideline, 2014]. Previous prostatectomy and/or prostate radiotherapy is allowed.
- •3.Willing to give informed consent in writing
- •4.Willing and able to attend the scheduled study visits and to comply with the study procedures
- •5.Testosterone level > 250 ng/dL
- •6.PSA level = 4 ng/mL
- •Exception: for subjects who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
- •7.Life expectancy > 1 year
- •8.Body Mass Index between 18.5 and 35.0 kg/m2 inclusive
- •9.ECOG score of =2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including gonadotrophin-releasing hormone (GnRH) receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit (with a maximum of 2 previous treatment cycles allowed in case of GnRH analog treatment)
- •2.Scheduled for prostatectomy or prostate radiotherapy during study period
- •3.Any subject at risk as per Investigator’s judgement for urinary obstruction or spinal cord compression due to potential testosterone surge
- •4.Alanine aminotransferase (ALT) or aspartate transaminase (AST) =2x upper limit of normal (ULN)
- •5.Estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <50 mL/min/1.73m2 at screening visit
- •6.Has received an investigational drug within the last 28 days before Visit 2 (Cycle 1 Day 1) or longer if considered by the Investigator to possibly influencing the outcome of this study
- •7.History or presence of any malignancy other than adequately treated squamous cell /basal cell carcinoma of the skin within the last five years
- •8.Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion. A profound risk-benefit assessment should be done when the subject is suffering from diabetes mellitus, osteoporosis or cardiovascular disease because of possible adverse events
- •9.History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study medication
- •10.Hypersensitivity to GnRH and its analogues
- •11.Other abnormal laboratory results which in the judgment of the Investigator would affect the subject's health or the outcome of the study
- •12.Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
研究者
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