Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).
详细描述
Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •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
- •Prior treatment with mTOR or PI3K inhibitors
- •Patients with more than 2 prior systemic treatment regimens
- •Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEZ235
Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
干预措施: BEZ235 (Drug)
Everolimus
Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
干预措施: Everolimus (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to approx. 18 months
PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.
次要结局
- Objective Response Rate(up to approx. 18 months)
- Overall Survival (OS)(up to approx. 30 months)
- Time to Treatment Failure (TTF)(up to approx. 18 months)