A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134640
• Other study ID #: ESST
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: May 8, 2014
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: May 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy)

Exclusion Criteria:

• Subjects who are not eligible for Erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to Erbitux

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Foundation	Chiayi
Taiwan	Chiayi Christian Hospital	Chiayi
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	Chang Gung Medical Foundation	Keelung
Taiwan	Chang Gung Medical Foundation	LinKou
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Medical Center, Liou Ying	Tainan
Taiwan	Chi Mei Medical Center, Yongkang	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Tainan Municipal Hospital	Tainan
Taiwan	Buddhist Tzu Chi General Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toxicity of Erbitux in clinical practice	To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer.	Till 28 days after last dose of Erbitux	Yes