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Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00113776
First received: June 10, 2005
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.


Condition Intervention Phase
Colorectal Cancer
 Drug: ABX-EGF
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer

Resource links provided by NLM:

Drug Information available for: Panitumumab
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of Adverse events
  • Changes in Lab values
  • Incidence of HAHA formation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113776

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00113776     History of Changes
Other Study ID Numbers: 20030194
Study First Received: June 10, 2005
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Metastatic Colorectal Cancer, Colon
Colorectal, Rectal Cancer, EGFr
Metastatic, Cancer, ABX-EGF
Panitumumab, Clinical Trial
Immunex, Abgenix, Amgen

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 May 16, 2013