Phase IV, Open-label, Multi-center, Single-arm Study of the Safety and Efficacy of Everolimus (Afinitor) in Adult Patients With Locally Advanced, Unresectable or Metastatic, Well Differentiated Progressive Pancreatic Neuroendocrine Tumors (pNET) in China.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
详细描述
This was an open-label, multicenter, single-arm clinical study to evaluate the safety and efficacy of everolimus in Chinese adult patients with locally advanced, unresectable or metastatic, well differentiated progressive pancreatic neuroendocrine tumors. The inclusion and exclusion criteria, as well as the dosing and dose modification criteria are designed according to the approved Chinese Package Insert. The planned sample size of the study was approximately 60 subjects.
Subjects who were eligible received the treatment with everolimus provided by sponsor to treat pNET and followed the visit schedule in the protocol to collect safety and efficacy data until progression of disease, unacceptable toxicity, death, protocol deviation or other reason that may lead to discontinuation before the end of study. All subjects were followed-up for survival status every 6 months by the investigator until death, lost to follow-up, withdrawal of consent for survival or end of study.
The "End of study" is defined as either at least 75% of subjects have completed survival follow up or all subjects discontinued study treatment or the last subject finished 5-year survival follow up, whichever comes first. Final analysis was conducted at the end of the study.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histological confirmed G1 or G2 pancreatic neuroendocrine tumors(pNETs) (WHO 2010)
- •Patients must have radiological documentation of progression of disease per RECIST 1.1 within 12 months prior to enrollment.
- •Measurable disease per RECIST 1.1 criteria using triphasic computed tomography (CT) scan or multiphase MRI for radiologic assessment.
- •everolimus treatment which is recommended by the treating physician
排除标准
- •Hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
- •Patient who is unwilling to receive Afinitor treatment due to any reason.
- •Pregnant or nursing (lactating) women,
- •Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
- •Use of an investigational drug within the 30 days prior to enrollment
研究组 & 干预措施
everolimus (single arm)
Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.
干预措施: everolimus (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period of 30 days, up to a maximum duration of approximately 5 years.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), SAEs, AEs and SAEs on grade 3 or 4, and suspected to be related to the study drug.
次要结局
- Overall Survival (OS)(Up to approximately 7 years and 6 months.)
- Progression Free Survival (PFS) by Investigator Assessment Per RECIST 1.1(Up to approximately 2 years and 9 months)