A Single Arm, Multicenter Phase II Study of Everolimus in Patients With Metastatic Colorectal Adenocarcinoma Whose Cancer Has Progressed Despite Prior Therapy With an Anti-EGFR Antibody (if Appropriate), Bevacizumab, Fluoropyrimidine, Oxaliplatin, and Irinotecan-based Regimens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Everolimus (RAD001) 70 mg/week
干预措施: Everolimus (RAD001) (Drug)
Everolimus (RAD001) 10 mg/day
干预措施: Everolimus (RAD001) (Drug)
结局指标
主要结局
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Imaging every 8 weeks
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above)
Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Imaging every 8 weeks
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).
次要结局
- Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).(From the first day of treatment until 28 days after discontinuation of study treatment)
- Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 10mg/Day(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Progression-free Survival (PFS)(Imaging every 8 weeks)
- Overall Survival (OS)(Every 3 months)
- Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)
- Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week(Screening and Day 1 of cycles 2, 3, 4 and end of treatment)