A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Progression-free Survival (PFS) Per Local Radiological Review
研究概览
简要总结
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.
A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.
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
- •Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
- •Progressive disease within the last 12 months
- •Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT
排除标准
- •Patients currently requiring somatostatin analog treatment
- •Prior therapy with mTOR inhibitors or pasireotide
- •Patients with more than 2 prior systemic treatment regimens
- •Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy within the last 4 weeks
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Paseriotide LAR + Everolimus
everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
干预措施: Everolimus (Drug)
Paseriotide LAR + Everolimus
everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
干预措施: Pasireotide LAR (Drug)
Everolimus
everolimus 10 mg once daily po alone
干预措施: Everolimus (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Per Local Radiological Review
时间窗: Once 80 PFS events had occurred aproximately after 24 months
PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
次要结局
- Disease Control Rate (DCR) as Per Radiology Review(Once 80 PFS events had occurred)
- Overall Survival (OS) Using Kaplan Meier Method(Once 80 PFS events had occurred)
- PFS and the Predictive Probability of Success in Phase III(Once 105 PFS events had occurred occurred)
- Duration of Response (DoR)(Once 80 PFS events had occurred)
- Summary of Pharmacokinetics (PK) for Everolimus for AUClast(Cycle 2 Day 1)
- Summary of Pharmacokinetics (PK) for Everolimus for Tmax(Cycle 2 Day 1)
- Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg(Cycle 1 Day 21, Cycle 2 Day 29)
- Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR(Once 80 PFS events had occurred)
- Objective Response Rate (ORR) as Per Radiology Review(Once 80 PFS events had occurred)
- Summary of Pharmacokinetics (PK) for Everolimus for CL/F(Cycle 2 Day 1)
- Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin(Cycle 2 Day 1)