A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer
Both
Metastatic Colorectal Cancer
Trial Information
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety and toxicity of Erbitux in clinical practice
Outcome Description:
To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer.
Outcome Time Frame:
Till 28 days after last dose of Erbitux
Safety Issue:
Yes
Principal Investigator
Jade Lien
Investigator Role:
Study Director
Investigator Affiliation:
Merck Ltd., Taiwan
Authority:
Taiwan: Institutional Review Board
Study ID:
ESST
NCT ID:
NCT01134640
Start Date:
January 2008
Completion Date:
November 2010
Related Keywords:
- Metastatic Colorectal Cancer
- metastatic colorectal cancer
- mCRC
- post marketing surveillance
- Erbitux
- Cetuximab
- KRAS
- Colorectal Neoplasms
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