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Trial record 1 of 1 for:    Panitumumab, 20025405
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Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111774
Recruitment Status : Completed
First Posted : May 26, 2005
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 25, 2005
First Posted Date  ICMJE May 26, 2005
Last Update Posted Date May 14, 2013
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2006)
To assess Objective Response at Week 8 of Cycle 1
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinoma
Official Title  ICMJE An Open Label Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of ABX-EGF in Patients With Metastatic Colorectal Carcinoma
Brief Summary The purpose of this study is to determine if ABX-EGF is safe and efficacious in patients with metastatic colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Carcinoma
Intervention  ICMJE Drug: ABX-EGF
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 24, 2007)
150
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria: Cohort A: - Pathologic diagnosis of colorectal carcinoma fine needle aspiration or tissue biopsy - Metastatic colorectal carcinoma - Must have previously failed therapy with a fluoropyrimidine and either irinotecan or oxaliplatin; may have received both irinotecan and oxaliplatin; chemotherapeutic agents may have been given concurrently or sequentially. - May have received prior radiotherapy (target lesions should not have been irradiated) - Bidimensionally measurable disease - Paraffin-embedded tumor tissue available for immunohistochemistry (IHC) studies of epidermal growth factor receptor (EGFr) expression (archived tissue is acceptable) - Tumor-expressing EGFr by immunohistochemistry (staining must be 2+ or 3+ in greater than or equal to 10% of evaluated tumor cells; staining and evaluation to be conducted at a central laboratory) - ECOG score of 0 or 1 - Adequate hematologic, renal, and hepatic function Cohort B: - The same inclusion criteria from Cohort A will apply to Cohort B, with the exception of the following tumor expressing EGFr criterion:

*Cohort B will include subjects who have IHC staining of 1+ present in greater than 10% evaluated tumor cells, OR IHC staining of the sum of 1+, 2+ and 3+ present in greater than 10% evaluated tumor cells but with the sum of 2+ and 3+ present in less than 10% evaluated tumor cells Exclusion Criteria: Cohorts A and B: - Female subject (e.g., of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized or not abstinent) who is not willing to use an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) during the course of the study and for 6 months following the last ABX-EGF infusion - Female subject who is breast feeding or who has a positive serum pregnancy test within 72 hours prior to the first ABX-EGF infusion - Male subject who is not willing to use adequate contraception upon enrollment into this study and for 1 month following the last ABX-EGF infusion - Untreated brain metastases - Use of systemic chemotherapy or radiotherapy within 30 days prior to the first dose of ABX-EGF - Chemotherapy other than fluoropyrimidines, irinotecan or oxaliplatin for colorectal carcinoma. Leucovorin and levamisole are not considered as chemotherapy in this exclusion criterion. - Prior EGFr targeting agents - Prior investigational drugs with potential antitumor activity (experimental small molecules within 30 days prior to the first ABX-EGF infusion, experimental proteins/antibodies within 3 months prior to the first ABX-EGF infusion) - If prior history of cancer, other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, no treatment or active disease within 5 years - Myocardial infarction within past year - Left ventricular ejection fraction (LVEF) less than 45%, as measured by multiple-gated acquisition (MUGA) scan - Known to be HIV positive - History of any chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the interpretation of study results - Subject allergic to the ingredients of the study medication or to Staphylococcus Protein A - Unwilling or unable to comply with the study requirements

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00111774
Other Study ID Numbers  ICMJE 20025405
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amgen
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP