Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer

Amgen

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: ABX-EGF (panitumumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327119

20050216

Details and patient eligibility

About

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.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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