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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00327119 |
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.
Condition | Intervention | Phase |
---|---|---|
Metastatic Colorectal Cancer |
Drug: ABX-EGF (panitumumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase 2 Multicenter Single Arm Clinical Trial of ABX EGF (Panitumumab) Monotherapy in Japanese Subjects With Metastatic Colorectal Cancer Who Developed Progressive Disease or Relapsed While on or After Prior Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050216 |
Study First Received: | May 16, 2006 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00327119 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
EGFR Fully human Monoclonal antibody Panitumumab |
ABX-EGF AMG954 Colorectal Cancer Japan |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Antibodies, Monoclonal Oxaliplatin Antibodies Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Neoplasms Neoplasms by Site |