A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma
- The subject must have surgically unresectable metastatic colorectal carcinoma.
- The subjects who have received and failed Ilinotecan, oxaliplatin and
- ECOG PS 0-2
- Subjects with symptomatic cerebral metastasis
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response according to the RECIST criteria accessed every 6 weeks
Taku Seriu, MD
Bristol Myers K.K.
Japan: Pharmaceuticals and Medical Devices Agency
- Colorectal Carcinoma
- EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
- Colorectal Neoplasms