NCT02651987已完成2 期
Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
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
- 99
- 试验地点
- 32
- 主要终点
- Median Progression Free Survival (PFS)
研究概览
简要总结
This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.
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
- •Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ≤20%.
- •Positive somatostatin receptors type 2
- •Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks
排除标准
- •Grade 3 or rapidly progressive (within 12 weeks) NET
- •Any NET other than pancreatic and midgut
- •Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
- •Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
研究组 & 干预措施
Lanreotide Autogel®
Experimental
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
干预措施: Lanreotide autogel 120 mg (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS)
时间窗: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.
次要结局
- Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin(Baseline (Day 1) and end of study (approximately 64 weeks))
- Objective Response Rate (ORR)(Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort))
- Median Duration of Stable Disease(From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort)
- Factors Associated With PFS(Screening/Baseline (Day 1))
- Mean Change From Baseline in Number of Stools and Flushing Episodes(Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort))
- Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)(Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort))
- Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)(Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort))
- Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)(Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort))
- Median Time to Progression(From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort)
- Percentage of Subjects Alive and Progression Free(Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort))
- Overall Survival(From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort)
- Disease Control Rate (DCR)(Weeks 24 and 48)
- Best Overall Response Rate(From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort)
- Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)(Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort))
- Mean Change From Baseline in Nonspecific Tumour Biomarkers(Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort))
- Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon(Baseline (Day 1) and end of study (approximately 64 weeks))
研究者
研究点 (32)
Loading locations...
相似试验
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
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 daysEUCTR2014-005607-24-ESIpsen Innovation100