EUCTR2006-007055-41-LT进行中（未招募）不适用
A phase II, open-label, multicentre study to evaluate the pharmacodynamic profile, the efficacy and the safety of a 6-month sustained-release formulation of triptorelin in patients with prostate cancer - Not applicable
Beaufour Ipsen Pharma - 24, rue Erlanger 75016 Paris FRANCE0 个研究点目标入组 12 人开始时间: 2007年3月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- •All screened patients must fulfil the following:
- •1) Give written (personally signed and dated) informed consent before completing any study-related procedure;
- •2) Be 18 years old or over;
- •3) The patient must have a histologically-confirmed diagnosis of prostate cancer, either locally advanced or metastatic or a biological and/or clinical relapse after a curative treatment like radical prostatectomy, external radiotherapy or curietherapy amenable to androgen deprivation therapy;
- •4) Have a life expectancy of at least twelve months;
- •5) Have WHO ECOG performance status score < ou = 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A screened patient will not be included in the study if he:
- •1) Has undergone a surgical castration;
- •2) Has undergone any surgery for prostate cancer within 2 weeks of baseline;
- •3) Has undergone radiation therapy for prostate cancer within 2 months of baseline;
- •4) Has undergone hormone therapy (GnRH analogue, oestrogens or steroid anti-androgens) within 3 months of baseline (previous treatment with non-steroidal anti-androgens is permitted) or could be under the effects of any hormonal therapy;
- •5) Has undergone any of the following treatments for prostate cancer within 2 months of baseline: immunotherapy, chemotherapy, biological response modifiers (cytokines);
- •6) Was treated with any other investigational medicinal product (IMP) within the last 90 days before study entry;
- •7) Was treated with over-the-counter or alternative medical therapies that have an oestrogenic or anti-androgenic effect within the three months of baseline;
- •8) Has a risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy);
- •9) Has a serum testosterone level below 150 ng/dL at screening;
- •10) Has a history of hypersensitivity to the IMP or drugs with a similar chemical structure;
- •11) Has any condition that may preclude subcutaneous injection;
- •12) Presents with known brain metastasis or leptomeningeal involvement;
- •13) Presents with other serious illness or medical condition;
- •- Active or uncontrolled infection,
- •- Any medical condition that might be aggravated by treatment or which could not be controlled: patients with concurrent heart failure New York Heart Association (NYHA) class III-IV or patients with severe/unstable angina pectoris, patients with myocardial infarction within 6 months, patients with history of cerebrovascular disease, and/or poorly controlled hypertension, patients who experienced venous thrombosis within six months of baseline, or have hypercalcaemia (calcium >2.9 mmol/L);
- •14) Has received a diagnosis of any other cancer, without a history of stability/remission, within 5 years of screening, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin;
- •15) Is, in the opinion of the Investigator, unable to comply fully with the protocol and the study instructions, or presents any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. psychological, familial, sociological or geographical conditions).
- •16) Have inadequate blood parameters;
- •Granulocytes < or = 2.0x10^9/L,
- •Platelets < or = 100x10^9/L,
- •Haemoglobin < 9 g/dL,
- •17) Have normal hepatic function;
- •Bilirubin >1.5xUNL,
- •ASAT/ALAT >2.5xUNL (and >5xUNL if liver metastasis),
- •Alkaline phosphatase >2.5xUNL (and >5xUNL if liver or bone metastasis),
- •18) Have normal renal function;
- •Creatinine >1.5xUNL.
研究者
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