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

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT01134640
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-06-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and toxicity of Erbitux in clinical practice	Till 28 days after last dose of Erbitux	To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer.

Trial Locations

Locations (11)

Chang Gung Medical Foundation; 🇨🇳 LinKou, Taiwan

Chiayi Christian Hospital; 🇨🇳 Chiayi, Taiwan

Buddhist Tzu Chi General Hospital; 🇨🇳 Taipei, 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

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

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