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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00327119
First received: May 16, 2006
Last updated: September 11, 2009
Last verified: September 2009
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Estimated Enrollment: 50
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327119

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00327119     History of Changes
Other Study ID Numbers: 20050216
Study First Received: May 16, 2006
Last Updated: September 11, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
EGFR
Fully human
Monoclonal antibody
Panitumumab
ABX-EGF
AMG954
Colorectal Cancer
Japan

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014