A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 25
- 主要终点
- Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
研究概览
简要总结
The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Everolimus 10 mg/day
Participants received 10 mg per day of Everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
干预措施: Everolimus (Drug)
Placebo
Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
干预措施: Everolimus Placebo (Drug)
结局指标
主要结局
Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
时间窗: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
次要结局
- Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})(Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
- Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin(Day 1 of every cycle (28 days/cycle) throughout the study)
- Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)(Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1)
- Overall Survival(Baseline, to death- no time limit)
- Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response(Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
- Evaluation of Pharmacokinetics (PK) Parameter: CL/F(Day 1 of every cycle (28 days/cycle) throughout the study)
- Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)(Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1)
- Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%(Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)(on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation)
- Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last(Day 1 of every cycle (28 days/cycle) throughout the study)
- Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)(Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1)
- Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)(Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1)
- Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)(Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1)
- Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response(Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)(on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation)
- Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration(Day 1 of every cycle (28 days/cycle) throughout the study)
- Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier(3 months, 6 months)