An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2014-08-05
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Ltd., India
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)

• Subjects with KRAS wild-type status of tumour tissue

• Chemotherapy naïve subjects

• Subject who have signed written informed consent (as per institutional protocol)

Exclusion Criteria:

• As per summary of product characteristics of cetuximab