EUCTR2004-002871-18-ES进行中（未招募）不适用
Phase II, open, single group,multicentre study to evaluate the efficacy and safety of Somatuline Autogel® (120 mg) administered every 4 weeks by deep subcutaneous injection in the tumour´s growth stabilization of patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy
IPSEN PHARMA, S.A.0 个研究点开始时间: 2006年2月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •1. The patient must give written informed consent prior to any study-related procedure. Informed consent must be given in writing except for patients who were unable to do it, in this case witnessed oral informed consent will be accepted.
- •2. Patients from both genders and over 18 years of age.
- •3. Patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification.
- •4. Patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours), present measurable disease (1).
- •(1) measurable disease: existence of at least one lesion which can be accurately
- •measured in at least one dimension and with longest diameter =20 mm using
- •conventional techniques or =10 mm with CT spiral scan.
- •5. Patients with progressive disease in the previous 6 months before their inclusion in the study. Is is needed to demonstrate the appearance of one or more new lesions or an increase =20% of the sum of the longest diameters of target lesions (2) or an unequivocal progression of not target lesions (3).
- •(2) target lesions: all measurable lesions up to a maximum of 5 per organ and
- •10 lesions in total. Size (lesions with the longest diameter) and their
- •suitability for accurate repeated measurements will be taken into account for
- •their selection.
- •(3) not target lesions: all lesions, or disease locations (e.g. ascites, pleural
- •effusion), not regarded as target lesions.
- •6. Patients with 0-2 punctuation in the ECOG Scale (Eastern Cooperative Oncological Group) for general condition assessment.
- •0 Fully active, able to carry on all pre-disease performance without restriction.
- •1 Restricted in physically strenuous activity but ambulatory and able to carry
- •out work of light or sedentary nature, e.g., light house work, office work.
- •2 Ambulatory and capable of all selfcare but unable to carry out any work
- •activities. Up and about more than 50% of awaking hours.
- •3 Capable of only limited selfcare, confined to bed or chair more than 50% of
- •awaking hours.
- •4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or
- •7. Patients with positive (111-In-DTPA-D-Phe) octreotide scintigraphy.
- •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
- •1. Patients with surgical removable localised disease.
- •2. Patients with progressive disease in the first six months of being diagnosed.
- •3. Patients with carcinoid tumours which cause intestinal obstruction.
- •4. Patients with life expectancy under 12 weeks.
- •5. Patients who have received treatment with somatostatine analogues during the 6 months before being included in the study.
- •6. Patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned during the study.
- •7. Patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.
- •8. Breast-feeding or pregnant women (Beta-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures.
- •9. Patients with physical comorbidity or mental or social alteration that prevent them to understand and carry out the treatment.
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