A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.
All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.
详细描述
This is a post marketing surveillance (PMS), prospective study to collect safety information from more than 600 subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type metastatic colorectal cancer (mCRC) treated with Erbitux as final evaluable cases. This PMS is requested by the Korean Regulatory Authorities because after removal of an orphan drug in Korea, there is a requirement to investigate more than 600 patients during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.
This PMS study is planned to be conducted within 6 years from the removal date of orphan drug in approximately 50 institutions in Korea.
OBJECTIVES
The objective of the study is to analyse the safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.
Primary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux ( i.e. in EGFR expressing, KRAS wild-type mCRC subjects in combination with chemotherapy, or as a single agent in subjects who failed oxaliplatin and irinotecan based therapy and who are intolerant to irinotecan)
排除标准
- •Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux
结局指标
主要结局
Safety
时间窗: Initial treatment period to final treatment period
Incidence and severity of all adverse events, regardless of the causal relationship to Erbitux
次要结局
- Clinical efficacy(The evaluation date to show best tumour response during the treatment of Erbitux)