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Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

NCT00113763•Amgen

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
•Metastatic colorectal carcinoma
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
•Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
•Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
•Unidimensionally measurable disease
•Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
•At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
•Adequate hematologic, renal and hepatic function

Exclusion Criteria

•Symptomatic brain metastases requiring treatment
•History or evidence of interstitial pneumonitis or pulmonary fibrosis
•Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
•Prior epidermal growth factor receptor (EGFr) targeting therapies
•Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.

Key Dates

Start Date

January 1, 2004

Primary Completion Date

October 1, 2008

Completion Date

June 1, 2009

Last Updated

November 7, 2022

Enrollment

463

ACTUAL participants

Conditions

Colorectal CancerMetastases

Interventions

Best supportive care

OTHER

Panitumumab

DRUG

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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