NCT02275338已完成2 期
An International, Multicentric, Prospective, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 MG Associated to Standard of Care in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
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
- 52
- 试验地点
- 1
- 主要终点
- Percentage of Responders Before or at Day 7
研究概览
简要总结
To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Written informed consent before any study related procedure
- •Male and female patients age 18 years or older at time of enrollment
- •Diagnosis of intestinal obstruction of malignant origin
- •In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study
- •Confirmed as inoperable after surgical advice
- •Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours
- •Estimated life expectancy 1 month or more
排除标准
- •Operable obstruction or subobstruction
- •Bowel obstruction due to a non-malignant cause
- •Signs of bowel perforation
- •Prior treatment with somatostatin or any other analogue within the previous 60 days
- •A known hypersensitivity to any of the study treatments or related compounds
- •Previous participation in this study
- •Is likely to require treatment during the study with drugs that are not permitted by the study protocol
- •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
研究组 & 干预措施
Lanreotide Autogel
Experimental
120mg administered via deep subcutaneous injection at Day 0 and Day 28.
干预措施: Lanreotide Autogel (Drug)
结局指标
主要结局
Percentage of Responders Before or at Day 7
时间窗: From Day 0 to Day 7
The primary endpoint assessed the percentage of responding subjects before or at Day 7. A responder was defined as a subject experiencing ≤2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Day 7 (for subjects without NGT at baseline), or as a subject in whom the NGT had been removed during at least 3 consecutive days at any timepoint between Day 0 and Day 7 without vomiting recurrence (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.
次要结局
- Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1(From Day 0 to Day 28)
- Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1(Days 0, 7, 14 and 28)
- Percentage of Responders in Phase 1(From Day 0 to Day 28)
- Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1(Days 0, 7, 14 and 28)
- Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1(Days 0, 7, 14 and 28)
- Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1(Days 0, 7, 14 and 28)
- Percentage of Responders Before or at Phase 2 Timepoints(From Day 0 to Day 56)
- Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2(Days 0, 35, 42 and 56)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in AcromegalyAcromegalyNCT02493517Ipsen128
进行中（未招募）
1 期
Efficacy and safety of lanreotide Autogel¿ 120 mg administered every 14 days in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel¿ 120 mgadministered every 28 dayswell differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumoursMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005607-24-ITIPSEN INNOVATIO99
进行中（未招募）
1 期
Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 dayswell differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumoursMedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005607-24-PLIpsen Innovation100
进行中（未招募）
1 期
Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 dayswell differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumoursMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005607-24-DEIpsen Innovation100
进行中（未招募）
1 期
Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 dayswell differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumoursMedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005607-24-DKIpsen Innovation100