NCT03947762终止不适用
Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 54
- 试验地点
- 46
- 主要终点
- Progression-free survival (PFS) rate at 24 months
研究概览
简要总结
The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects aged ≥ 18
- •Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
- •Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
- •Subject with Eastern Cooperative Oncology Group (ECOG) ≤2
排除标准
- •Subject who is participating in an interventional study
- •Pregnant or breast-feeding women
- •Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours
结局指标
主要结局
Progression-free survival (PFS) rate at 24 months
时间窗: 24 months
To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.
次要结局
- Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels(Every 6 months up to 24 months)
- Changes of Chromogranin A (CgA) levels(Every 6 months up to 24 months)
- Progression-free survival (PFS) rate at 12 months(12 months)
- Medical tumour-related intervention(Baseline)
- Changes of pro-Brain Natriuretic Peptide (proBNP) levels(Every 6 months up to 24 months)
- Time from diagnosis to first therapeutic intervention(Baseline)
- Median time to lanreotide discontinuation(Up to 24 months)
- Changes of Glycated hemoglobin (HbA1c) levels(Every 6 months up to 24 months)
- Quality of Life (QoL)(From baseline up to 24 months)
- Patient satisfaction(Baseline visit and 12 months)
研究者
研究点 (46)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable PatientsMalignant Intestinal ObstructionNCT01076803University Hospital, Ghent40
已完成
2 期
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian CancerOvarian NeoplasmsNCT00710762Boehringer Ingelheim89
撤回
不适用
Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical PracticeNeuroendocrine TumorsNCT03895463Ipsen
已完成
不适用
Somatuline Predictive Factors in Acromegaly and NETNeuroendocrine TumoursAcromegalyNCT01840449Ipsen156
进行中（未招募）
3 期
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube CancerOvarian NeoplasmFallopian Tube NeoplasmsPeritoneal NeoplasmsNCT05257408Corcept Therapeutics381