EUCTR2011-001193-26-CZ进行中（未招募）不适用
An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.
Acino Supply AG0 个研究点目标入组 145 人开始时间: 2011年12月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 145
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 between 18 and 89 years of age at the start and for the duration of the study
- •2. Diagnosis of locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy
- •3. Testosterone values at Screening (>1.5 ng/mL)
- •4. Life expectancy of at least 6 months
- •5. Written informed consent
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 109
排除标准
- •1. Hypersensitivity to Zoladex or to other gonadotropin releasing hormone (GnRH) analogs
- •2. Concomitant treatment with any GnRH analogs. Patients who previously underwent an intermittent treatment scheme may be included if no more than 2 treatment cycles were received. A treatment cycle is
- •defined as the continuous and repeated administration of a GnRH analog (according to the prescribing information) until a discontinuation of treatment based on the patient's physical and / or disease status as
- •judged by the investigator. The re-initiation of a subsequent GnRH analog administration (based on medical judgement) after the treatment discontinuation is defined as the start of a new treatment cycle.
- •3. Considered for curative therapy i.e. radical prostatectomy or radiotherapy within 2 months from inclusion
- •4. Cancer diagnosis within the last 5 years except prostate cancer, low grade bladder cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
- •5. Clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or other condition including alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator (using the ECOG [Eastern Cooperative Oncology Group] performance scale; patients who have an ECOG performance status of =3 will be excluded).
- •6. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures
- •7. Previous participation in this study
- •8. Known allergy against one of the ingredients in the test and reference preparation
- •9. Having used any investigational medication or medical device in the 12 weeks prior to Screening or scheduled to use another investigational medication or medical device during the study
- •10. Participation in another clinical study within 30 days before screening
- •11. Absence of effective contraception (i.e. use of condoms or sexual abstinence)
- •12. Employee at the investigational site, relative or spouse of the investigator
研究者
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