Status:
COMPLETED
Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer
Lead Sponsor:
Amgen
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese su...
Eligibility Criteria
Inclusion
- Metastatic colorectal adenocarcinoma;
- Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells).
Exclusion
- Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment;
- Subjects who have prior EGFr targeting agents;
- Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00327119
Start Date
April 1 2006
Last Update
September 14 2009
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