First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 主要终点
- Safety: Number of Participants With Serious and Specific Adverse Events
研究概览
简要总结
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
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
- •Previously untreated metastatic colon or rectal cancer;
- •Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.
排除标准
- •Prior chemotherapy for metastatic colon or rectal cancer;
- •Planned radiotherapy for underlying disease;
- •central nervous system metastases;
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
研究组 & 干预措施
Bevacizumab
Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
干预措施: Bevacizumab (Drug)
Bevacizumab
Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
干预措施: Fluoropyrimidine-based Chemotherapy (Drug)
结局指标
主要结局
Safety: Number of Participants With Serious and Specific Adverse Events
时间窗: Up to approximately 3 years
A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.
次要结局
- Efficacy: Overall Survival(Up to approximately 3 years)
- Efficacy: Progression-free Survival(Up to approximately 3 years)
- Efficacy: Time to Disease Progression(Up to approximately 3 years)