A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment
This study has been completed.
Sponsor:
Merck KGaA
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01134640
First received: May 17, 2010
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
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.
| Condition |
|---|
|
Metastatic Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment |
Resource links provided by NLM:
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Safety and toxicity of Erbitux in clinical practice [ Time Frame: Till 28 days after last dose of Erbitux ] [ Designated as safety issue: Yes ]To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer.
| Enrollment: | 286 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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)
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134640
Locations
| Taiwan | |
| Chiayi Christian Hospital | |
| Chiayi, Taiwan | |
| Chang Gung Medical Foundation | |
| 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 | |
| Taichung Veterans General Hospital | |
| Taichung, Taiwan | |
| Chung Shan Medical University Hospital | |
| Taichung, Taiwan | |
| Chi Mei Medical Center, Liou Ying | |
| Tainan, Taiwan | |
| National Cheng Kung University Hospital | |
| Tainan, Taiwan | |
| Chi Mei Medical Center, Yongkang | |
| 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, Taiwan | |
Sponsors and Collaborators
Merck KGaA
Investigators
| Study Director: | Jade Lien | Merck Ltd., Taiwan |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01134640 History of Changes |
| Other Study ID Numbers: | ESST |
| Study First Received: | May 17, 2010 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Merck KGaA:
|
metastatic colorectal cancer mCRC post marketing surveillance |
Erbitux Cetuximab KRAS |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan |
Cetuximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013