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临床试验/NCT01732783
NCT01732783已完成不适用

Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

Amgen0 个研究点目标入组 213 人开始时间: 2012年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Amgen
入组人数
213
主要终点
Total Number of Panitumumab Infusions

研究概览

简要总结

The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Total Number of Panitumumab Infusions

时间窗: 12 months

Percentage of Participants With at Least One Panitumumab Dose Reduction

时间窗: 12 months

Percentage of Participants With at Least One Panitumumab Dose Delay

时间窗: 12 months

Cumulative Dose of Panitumumab

时间窗: 12 months

Maximum Dose of Panitumumab

时间窗: 12 months

Duration of Exposure of All Concomitant Chemotherapy

时间窗: 12 months

Duration of exposure is the time from the first date to the last date of chemotherapy administration.

Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay

时间窗: 12 months

Duration of Panitumumab Exposure

时间窗: 12 months

Duration of exposure is the time from the first to the last panitumumab infusion

Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction

时间窗: 12 months

Reasons for Discontinuation of Panitumumab

时间窗: 12 months

Mean Interval Between Panitumumab Infusions

时间窗: 12 months

次要结局

  • Number of Participants With Resectability(12 months)
  • Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation(12 months)
  • Percentage of Participants With an Overall Response(12 months)
  • Number of Participants With at Least One Hospitalization(12 months)
  • Duration of Hospital Stay(12 months)
  • Type of Post-Panitumumab Anti-cancer Treatment(12 months)
  • Reasons for Hospitalization(12 months)
  • Types of Hospital Visit(12 months)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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