NCT00353496已完成3 期
Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 264
- 试验地点
- 67
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
- •No hormone related symptoms
- •Well or moderately differentiated tumour confirmed by histology
- •Tumour lesions which are measurable by a CT or MRI scan
排除标准
- •Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
- •Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
- •Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
- •Pregnant or lactating
- •Females must use adequate contraception during the study
研究组 & 干预措施
lanreotide (Autogel formulation)
Experimental
干预措施: lanreotide (Autogel formulation) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year
Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
次要结局
- Change in the Global Health Status Quality of Life Assessment(Week 12 to Week 96 (last visit))
- Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels(Week 12 to Week 96 (last visit))
- Pharmacokinetic Profile of Lanreotide(Week 4, 12, 24, 36, 48, 72, 96)
- Percentage of Patients Still Alive Based on Available Overall Survival Data(Randomisation to death or last visit, up to 321 weeks)
- Percentage of Patients Alive & Without Disease Progression(Week 48 & 96)
研究者
研究点 (67)
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