A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 656
- 试验地点
- 9
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
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
- •Male or female patients > 18 years old
- •Histologically or cytologically confirmed and documented gastric adenocarcinoma
- •Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
- •ECOG Performance Status of < 2
- •Lab parameters within specifically defined intervals
- •Able to provide written informed consent
排除标准
- •Patients who have received > 2 prior systemic therapies for advanced disease
- •Administration of another anticancer therapy within 3 weeks prior to randomization
- •Chronic treatment with steroids or another immunosuppressive agent
- •Major surgery within 2 weeks prior to randomization
- •Patients with CNS metastases
- •Any other severe and/or uncontrolled medical condition
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Everolimus + BSC
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
干预措施: Everolimus (Drug)
Everolimus + BSC
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
干预措施: Best Supportive Care (BSC) (Drug)
Placebo + BSC
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
干预措施: Everolimus placebo (Drug)
Placebo + BSC
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
干预措施: Best Supportive Care (BSC) (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 2.5 years
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
次要结局
- Overall Response Rate (ORR)(2.5 years)
- Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5(Week 5)
- Progression Free Survival (PFS)(2.5 years)
- Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores(2.5 years)
- Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score(2.5 years)
- Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5(Week 5)