EUCTR2013-002194-22-GB进行中（未招募）1 期
A Phase IV, Multicentre, Open label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients receiving Deep Subcutaneous Administrations of Somatuline®(lanreotide) Autogel® to treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET). - Circulating Tumour Cells in Somatuline Autogel treated NET patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
入选标准
- •Patients MUST satisfy all of the following entry criteria before they will be allowed to participate in the study:
- •Provision of written informed consent prior to any study related procedures. In this study consent may be provided by the legal guardian or carer. See section 5.2
- •Patients (either sex) must be 18 years or older.
- •Patients must have a documented diagnosis of a functioning midgut NET.
- •In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of <20% will be recruited.
- •The clinically appropriate treatment for the patient must primarily be monotherapy with a somatostatin analogue.
- •Patients must have had either a positive somatostatin receptor scintigraphy result or a positive 68 Gallium-DOTATATE PET imaging result.
- •Patients must have a documented urinary or plasma 5-HIAA result within the year prior to study entry which is above the laboratory reference range.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •If any of the following apply, the patient MUST not enter/continue in the study:
- •If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
- •The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
- •The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
- •The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
- •The patient requires medical treatment for the symptoms of the NET other than primarily monotherapy with a somatostatin analogue.
- •The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.
- •The patient has a history of hypersensitivity to drugs with a similar chemical structure.
- •Females of childbearing potential must provide a negative pregnancy test at the start of the study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as being post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- •The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
研究者
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