A Phase 3, Single-arm, Open-label, Multicentre Study to Assess the Efficacy and Safety of Deep Subcutaneous Injections of Lanreotide Autogel® 120 mg Administered Every 28 Days in Chinese Participants With Unresectable, Locally Advanced or Metastatic Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 43
- 试验地点
- 14
- 主要终点
- Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
研究概览
简要总结
This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs.
The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.
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
- •Capable of giving signed informed consent
- •Male or female of 18 years of age or older when informed consent is obtained
- •Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification
- •Has an unresectable metastatic or locally advanced NET.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2.
排除标准
- •Participants with poorly differentiated Gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), high-grade GEP-NEC and goblet cell carcinoid.
- •Has been treated with octreotide acetate long-acting release or lanreotide acetate Autogel formulation within 8 weeks prior to screening tests or lanreotide PR 40 mg within 4 weeks prior to screening tests.
- •Has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests.
- •Has been treated with mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase (MTK) inhibitors within 4 weeks prior to screening tests.
研究组 & 干预措施
lanreotide Autogel 120 mg
Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).
干预措施: Lanreotide autogel (Drug)
结局指标
主要结局
Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
时间窗: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
The CBR was defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or continued stable disease (SD) until the time of assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
次要结局
- Progression Free Survival (PFS) by BICR Within Weeks 24 and 48(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48)
- Overall Survival (OS) at the End of the Main Intervention Period(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period))
- Time to Progression (TTP) During Main Intervention Period(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48)
- Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48)
- Clinical Benefit Rate Assessed by BICR at Week 48(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48)
- Overall Response Rate (ORR) at Weeks 24 and 48(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48)
- Disease Control Rate (DCR) at Weeks 24 and 48(RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48)
- Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48(Weeks 24 and 48)
- Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48(Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48)
- Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48(Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48)
- Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48(Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48)