Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET) G1/G2 - A Pilot-Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 57
- 试验地点
- 10
- 主要终点
- Disease Control Rate (DCR) After 6 Months
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).
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
- •Provision of written informed consent prior to any study related procedures
- •Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Proliferation Index, Ki67-Index: 0 to ≤20%) confirmed by pathological/histological assessment
- •Progressive disease within 12 months before inclusion (RECIST 1.1: increase of >20% tumour load; by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)
- •Measurable disease according to RECIST 1.
- •Metastatic disease confirmed by CT/MRI.
- •Functioning or non-functioning NET (G1, G2).
- •Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT within 12 months prior to screening
排除标准
- •Has the diagnosis of Insulinoma
- •Has a diagnosis of a multiple endocrine neoplasia (MEN)
研究组 & 干预措施
Lanreotide Autogel 120mg & Temozolomide
Combination phase for first 6 months: Lanreotide Autogel 120 mg and Temozolomide.
Followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months of no treatment.
干预措施: Lanreotide Autogel 120 mg (Drug)
Lanreotide Autogel 120mg & Temozolomide
Combination phase for first 6 months: Lanreotide Autogel 120 mg and Temozolomide.
Followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months of no treatment.
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Disease Control Rate (DCR) After 6 Months
时间窗: 6 months
All tumour assessments were performed using the Response Evaluation Criteria In Solid Tumours (RECIST) criteria (1.1). Computer Tomography (CT-scan) or Magnetic Resonance Imaging (MRI) could be used for as method of tumour measurement and the same method of tumour measurement was used throughout the study for each subject. CT scans/MRI were performed at screening or baseline visit then at weeks 12, 24 and at early withdrawal or at anytime during the study in the case of any clinical or biological signs of tumour progression. The DCR was defined as the proportion of subjects with a response of CR, PR or SD after 6 months of combination treatment and was described in the ITT population along with its 95% Confidence Interval (CI) and was compared to 45% with an exact binomial proportion test. The Last Observation Carried Forward (LOCF) method was used to replace missing assessments at the end of the combination phase.
次要结局
- The Number of Subjects With a Biochemical Response Using CgA Levels After 12 Months(12 months)
- Pharmacokinetic (PK) Results: Lanreotide ATG 120 mg Serum Concentrations Within 12 Months(Baseline (week 1) and weeks 4, 12, 24 and 48)
- Duration of Response (DoR) Within 12 Months(12 months)
- Progression-Free Survival (PFS) Within 12 Months(12 months)
- Time To Response (TtR) Within 12 Months(12 months)
- The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months(6 months)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Core 30 Questionnaire (QLQ-C30): Mean Change From Baseline at 6 Months(6 months)
- DCR After 12 Months(12 months)
- The Number of Subjects With a Biochemical Response Using 5-Hydroxy-Indol-Amino-Acid (HIAA) Levels After 6 Months(6 months)
- The Number of Subjects With a Symptomatic Response After 6 Months(6 months)
- The Number of Subjects With a Symptomatic Response After 12 Months - Maintenance Phase(12 months)
- The Number of Subjects With a Biochemical Response Using 5-HIAA Levels After 12 Months(12 months)
- QoL Questionnaire QLQ-GI.NET21: Mean Change From Baseline at 12 Months(12 months)
- Quality of Life Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21): Mean Change From Baseline at 6 Months(6 months)
- EORTC QoL Questionnaire QLQ-C30: Mean Change From Baseline at 12 Months(12 months)
- DCR by O6-methylguanine-DNA Methyl-transferase (MGMT) Expression and Methylation and Somatostatin Receptor (SSTR) Expression After 6 Months(6 months)