EUCTR2006-005964-24-GB进行中（未招募）不适用
Pharmacokinetics, pharmacodynamics and safety of a new Leuprolide acetate 22.5 mg depot formulation, when given as palliative treatment to prostate cancer patients
Italfarmaco S.p.A.0 个研究点目标入组 20 人开始时间: 2007年1月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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 >= 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy;
- •2.life expectancy of at least 1 year;
- •3.World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2;
- •4.adequate renal function at screening as defined by serum creatinine <= 1.5 times the upper limit of normal (ULN) for the clinical laboratory;
- •5.adequate and stable hepatic function as defined by bilirubin <= 1.5 times the ULN and transaminases (i.e. AST, ALT) <= 2.5 times the ULN for the clinical laboratory at screening;
- •6.ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
- •7.signed written informed consent prior to inclusion in the study.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of brain metastases, taking into account medical history, clinical observations and symptoms; evidence of spinal cord compression, taking into account medical history, clinical observations and symptoms; evidence of severe urinary tract obstruction with threatening urinary retention, taking into account medical history, clinical observations and symptoms; presence of any tumour in the immediate vicinity which could cause cord compression; severe pain from extensive osseous deposits, taking into account medical history, clinical observations and symptoms; testosterone levels less than 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site; previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumour-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline; previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (no wash-out allowed); previous treatment with androgen receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed); previous orchiectomy, adrenalectomy or hypophysectomy; previous prostatic surgery within 2 weeks of baseline; previous local therapy to the primary tumour with a curative attempt other than surgery within 2 weeks of baseline; any investigational drug within 5 half-lives of its pharmacological action or 3 months, whichever is longer, before baseline; administration of 5-?-reductase inhibitors within 3 months before baseline; OTC or alternative medical therapies which have an estrogenic or anti-androgenic effect within the 3 months before baseline; haematological parameters outside 20% of the upper or lower limits of normal for the clinical laboratory at screening;
- •co-existent malignancy other than prostate cancer; uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: (? 160/100 mmHg) or symptomatic hypotension within 3 months before baseline; venous thrombosis within 6 months of baseline;
- •uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH-RH analogues); history of drug and/or alcohol abuse within 6 months of baseline; serious concomitant illness(es) or disease(s) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol; patients on anticoagulant therapy; blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients; known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation
- •history of the following prior to the study: immunization (within 4 weeks of baseline); flu shots (within 2 weeks of baseline); anaphylaxis; skin disease which would interfere with injection site evaluation; dermatographism will be documented at screening and followed up while on treatment
研究者
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