Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Progression Free Survival rate at 10 months (PFS@10m)
研究概览
简要总结
Primary Objective:
Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept.
Secondary Objectives:
To evaluate:
- Efficacy: Progression Free Survival (PFS)
- Efficacy: Overall Survival (OS)
- Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria
- Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L
- Safety
Exploratory Objective:
To collect blood and tumor samples to perform investigations for potential biomarker testing.
详细描述
Total study duration for a participant can be up to 28 months.
This trial is being conducted in countries where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
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 —（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
Aflibercept
Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
干预措施: Capecitabine (Drug)
Aflibercept
Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
干预措施: Aflibercept AVE0005 (Drug)
Aflibercept
Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine
干预措施: Oxaliplatin SR96669 (Drug)
结局指标
主要结局
Progression Free Survival rate at 10 months (PFS@10m)
时间窗: every 9 weeks, up to 28 months
次要结局
- Progression Free Survival (PFS) - Time(every 9 weeks, up to 28 months)
- Overall Survival (OS) - Time(every 9 weeks, up to 28 months)
- Assessment of Objective Response Rate (ORR)(every 9 weeks, up to 28 months)
- Total Score as a measure of Health Related Quality of Life(every 3 weeks, up to end of treatment)
- Number of participants with adverse events(up to 30 days after last treatment)