EUCTR2013-000799-14-NL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 patients with prostate cancer - 0080CA002
ovalon S. A.0 个研究点目标入组 142 人开始时间: 2015年7月23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 androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy is 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. Baseline testosterone level > 250 ng/dL
- •7. PSA level = 4 ng/mL
- •Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
- •8. Life expectancy > 1 year
- •9. Body Mass Index between 18.5 and 35 kg/m2 inclusive
- •10. 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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •1. Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens) within 6 months prior to the Screening visit
- •2. Scheduled for prostatectomy or radiotherapy during study period
- •3. ALT (SGOT) or AST (SGPT) =2x upper limit of normal (ULN)
- •4. moderate (stage 3B) or severe (stage 4 and 5) chronic kidney disease with an eGFR <45 mL/min/1,73m2
- •5. Has received an investigational drug within the last 28 days before the screening visit or longer if considered by the Investigator to possibly influencing the outcome of this trial
- •6. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last five years
- •7. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion
- •8. 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
- •9. Other abnormal laboratory results which in the judgment of the Investigator would affect the patient's health or the outcome of the trial
- •10. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
研究者
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