An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
- •Progressive disease within last 12 months (only patients with nonfunctional tumors)
- •Documented liver metastasis
- •Measurable disease per RECIST determined by multiphase MRI or triphasic CT
排除标准
- •Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
- •Previous treatment with mTOR inhibitors or pasireotide
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •Women who are pregnant or lactating
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Functional tumors, pre-treated
干预措施: Pasireotide LAR followed by Pasireotide LAR + Everolimus (Drug)
Functional tumors, treatment naïve
干预措施: Pasireotide LAR followed by Pasireotide LAR + Everolimus (Drug)
Nonfunctional tumors, pretreated 1
干预措施: Pasireotide LAR followed by Pasireotide LAR + Everolimus (Drug)
Nonfunctional tumors, pretreated 2
干预措施: Everolimus followed by Pasireotide LAR + Everolimus (Drug)
Nonfunctional tumors, treatment-naïve 1
干预措施: Pasireotide LAR followed by Pasireotide LAR + Everolimus (Drug)
Nonfunctional tumors, treatment-naïve 2
干预措施: Everolimus followed by Pasireotide LAR + Everolimus (Drug)
结局指标
主要结局
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
时间窗: 3 months
次要结局
- Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET(15 months)
- To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy(15 months)
- To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy(12 months)
- To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus(15 months)
- To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors(15 months)