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Study Complete
Sponsor ID
20050216

Phase 2 Study of ABX-EGF (panitumumab) in Japanese Subjects with m-colorectal cancer

Sponsor ID
20050216
Clinicaltrials.gov ID
NCT00327119
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 subjects with metastatic colorectal cancer.

Additional Study Details

Phase
Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
50
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
20+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Apr 2006 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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 Criteria:
    - 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