NCT00111774

Brief Summary

The purpose of this study is to determine if ABX-EGF is safe and efficacious in patients with metastatic colorectal cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2005

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

First QC Date

May 25, 2005

Last Update Submit

May 10, 2013

Conditions

Colorectal CancerCarcinoma

Keywords

Colon Cancer, Rectal CancerColorectal Carcinoma, EGFrMetastatic Cancer, ABX-EGFPanitumumab, AbgenixClinical Trial, Immunex, AmgenMetastatic Colorectal

Outcome Measures

Primary Outcomes (1)

  • To assess Objective Response at Week 8 of Cycle 1

Secondary Outcomes (3)

  • To evaluate additional measures of the clinical efficacy of ABX-EGF in subjects with metastatic colorectal carcinoma. (progression free survival, survival time, best overall response, and time to disease progression)

  • To determine the safety of ABX-EGF in subjects with metastatic colorectal carcinoma. (incidence of AEs, laboratory abnormalities, and other safety parameters)

  • To evaluate the safety and efficacy of ABX-EGF in subjects with lower tumor epidermal growth factor receptor (EGFr) expression

Interventions

ABX-EGFDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hecht JR, Patnaik A, Berlin J, Venook A, Malik I, Tchekmedyian S, Navale L, Amado RG, Meropol NJ. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer. 2007 Sep 1;110(5):980-8. doi: 10.1002/cncr.22915.

    PMID: 17671985RESULT

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinomaColonic NeoplasmsRectal NeoplasmsNeoplasm Metastasis

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2005

First Posted

May 26, 2005

Study Start

March 1, 2002

Last Updated

May 14, 2013

Record last verified: 2013-05