ABX-EGF (Panitumumab) Monotherapy in Subjects With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00089635
First received: August 9, 2004
Last updated: October 7, 2013
Last verified: October 2013
Results First Received: August 6, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Metastases
Intervention: Drug: ABX-EGF (panitumumab)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 11 August 2004 through 2 August 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Panitumumab Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.

Participant Flow:   Overall Study
    Panitumumab  
STARTED     203  
COMPLETED     160  
NOT COMPLETED     43  
Adverse Event                 2  
Death                 17  
Disease Progression                 12  
Lost to Follow-up                 3  
Withdrawal by Subject                 6  
Ineligibility determined                 1  
Not specified                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Panitumumab Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.

Baseline Measures
    Panitumumab  
Number of Participants  
[units: participants]
  203  
Age  
[units: years]
Median ( Inter-Quartile Range )
  62  
  ( 54 to 68 )  
Gender  
[units: participants]
 
Female     89  
Male     114  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     3  
Black or African American     34  
Hispanic or Latino     13  
White or Caucasian     151  



  Outcome Measures
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1.  Primary:   Objective Tumor Response Through Week 16   [ Time Frame: From enrollment through Week 16 ]

2.  Primary:   Duration of Response   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

3.  Secondary:   Objective Tumor Response Throughout the Study   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

4.  Secondary:   Time to Initial Objective Response   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

5.  Secondary:   Progression-free Survival Time   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

6.  Secondary:   Time to Disease Progression   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

7.  Secondary:   Time to Treatment Failure   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

8.  Secondary:   Duration of Stable Disease   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]

9.  Secondary:   Overall Survival   [ Time Frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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