EUCTR2015-001756-30-BG进行中（未招募）1 期
Open-label, multi-center, randomized parallel group study to assess the pharmacokinetic (PK) profile of Zoreline 10.8 mg goserelin subcutaneous implant (test product, Novalon S.A.) and of Zoladex® LA 10.8 mg goserelin subcutaneous implant (reference product, AstraZeneca UK Limited) in male patients with prostate cancer
ovalon S.A.0 个研究点目标入组 58 人开始时间: 2015年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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 Age 18 years (inclusive) or above
- •2. Histologically confirmed prostate adenocarcinoma and indicated for androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy are allowed.
- •3. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs
- •4. Willing to give informed consent in writing
- •5. Willing and able to attend the scheduled study visits and to comply with the study procedures
- •6. Testosterone level > 2.5 ng/mL at screening
- •7. PSA level =4ng/mL.
- •Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
- •8. Life expectancy > 1 year assessed at screening or within the last month
- •9. Body Mass Index between 18.5 and 35kg/m2 inclusive
- •10. ECOG score of =2 measured at screening
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Previous or current hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit. All other prohibited medications that are listed in Appendix 3 should not have been administered within the last 3 months prior the study drug administration
- •2. Scheduled for prostatectomy or prostate radiotherapy during study period
- •3. Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST) / serum glutamic oxaloacetic transaminase (SGOT) =2x upper limit of normal (ULN) or GGT =2.5 x upper limit of normal
- •4. Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history for chronic hepatic disease
- •Moderate or severe chronic kidney disease with an estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <60 mL/min/1,73m2
- •6. Has received an investigational drug within the last 28 days before the Screening visit or 5 times the half-life of the drug whichever is longer if considered by the investigator to possibly influencing the outcome of this trial
- •7. History or presence of any malignancy other than prostate cancer and 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], cardiovascular, gastrointestinal, pulmonary, or endocrine disease), that could confound interpretation of the study at investigator discretion
- •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 drug
- •10. Other abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
- •11. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
- •12. Have a prolonged QTc interval defined as mean QTcB > 450 ms at Screening. If the mean value of QTcB interval from the three measurements is above 450 ms, another triplicate ECG could be recorded once on the same day
- •13. Have a family history for prolonged QT interval including a history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or a personal history of syncope
- •14. Evidence or history for significant active cardiac disease (e.g., congestive heart failure, mitral valve regurgitation, endocarditis, coronary artery heart disease), or symptoms of angina pectoris or transient ischaemic attacks
研究者
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