NCT00326469已完成2 期
Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 30
- 试验地点
- 27
- 主要终点
- Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study).
研究概览
简要总结
To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification
- •patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease
- •patients with progressive disease in the previous 6 months before their inclusion in the study
- •patients with positive IN111 octreotide scintigraphy
排除标准
- •patients with surgically removable localised disease
- •patients with progressive disease in the first six months of being diagnosed
- •patients with intestinal obstruction due to a carcinoid tumour
- •patients who have received treatment with somatostatin analogues during the 6 months before being included in the study
- •patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study
- •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.
研究组 & 干预措施
1
Experimental
干预措施: lanreotide (Autogel formulation) (Drug)
结局指标
主要结局
Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study).
时间窗: Month 3, 6, 9, 12, 15, 18, 21 and 24
次要结局
- To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life(Month 3, 6, 9, 12, 15, 18, 21 and 24)
- Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel(Month 3, 6, 9, 12, 18, 21 and 24)
- Tolerance(All visits)
研究者
研究点 (27)
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