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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 ]

Measure Type Primary
Measure Title Objective Tumor Response Through Week 16
Measure Description Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
Time Frame From enrollment through Week 16  
Safety Issue No  

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.
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Objective Tumor Response Through Week 16  
[units: participants]
  6  

No statistical analysis provided for Objective Tumor Response 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. ]

Measure Type Primary
Measure Title Duration of Response
Measure Description Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  7  
Duration of Response  
[units: weeks]
Median ( 95% Confidence Interval )
  22.2  
  ( 16.1 to 28.4 )  

No statistical analysis provided for Duration of Response



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. ]

Measure Type Secondary
Measure Title Objective Tumor Response Throughout the Study
Measure Description Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Objective Tumor Response Throughout the Study  
[units: participants]
  7  

No statistical analysis provided for Objective Tumor Response Throughout the Study



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. ]

Measure Type Secondary
Measure Title Time to Initial Objective Response
Measure Description Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  7  
Time to Initial Objective Response  
[units: weeks]
Median ( Full Range )
  11  
  ( 7 to 23 )  

No statistical analysis provided for Time to Initial Objective Response



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. ]

Measure Type Secondary
Measure Title Progression-free Survival Time
Measure Description Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Progression-free Survival Time  
[units: weeks]
Median ( 95% Confidence Interval )
  8.1  
  ( 7.4 to 11.3 )  

No statistical analysis provided for Progression-free Survival Time



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. ]

Measure Type Secondary
Measure Title Time to Disease Progression
Measure Description Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Time to Disease Progression  
[units: weeks]
Median ( 95% Confidence Interval )
  8.3  
  ( 7.4 to 11.3 )  

No statistical analysis provided for Time to Disease Progression



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. ]

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Time to Treatment Failure  
[units: weeks]
Median ( 95% Confidence Interval )
  8.4  
  ( 8.1 to 11.3 )  

No statistical analysis provided for Time to Treatment Failure



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. ]

Measure Type Secondary
Measure Title Duration of Stable Disease
Measure Description

Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.

Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started.

Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  52  
Duration of Stable Disease  
[units: weeks]
Median ( 95% Confidence Interval )
  16.0  
  ( 15.3 to 22.9 )  

No statistical analysis provided for Duration of Stable Disease



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. ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.
Time Frame From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.  
Safety Issue No  

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.
Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

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.

Measured Values
    Panitumumab  
Number of Participants Analyzed  
[units: participants]
  158  
Overall Survival  
[units: months]
Median ( 95% Confidence Interval )
  9.0  
  ( 8.1 to 11.2 )  

No statistical analysis provided for Overall Survival




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00089635     History of Changes
Obsolete Identifiers: NCT00112944
Other Study ID Numbers: 20030250
Study First Received: August 9, 2004
Results First Received: August 6, 2010
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration