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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;   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 
Overall Participants Analyzed 
[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
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Time Frame First dose date through the safety follow-up visit. The median time frame is 2.6 months.
Additional Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Panitumumab
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   200/203 (98.52%) 
Blood and lymphatic system disorders   
ANAEMIA † 1   
# participants affected / at risk   14/203 (6.90%) 
Eye disorders   
CONJUNCTIVITIS † 1   
# participants affected / at risk   11/203 (5.42%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION † 1   
# participants affected / at risk   13/203 (6.40%) 
ABDOMINAL PAIN † 1   
# participants affected / at risk   31/203 (15.27%) 
ABDOMINAL PAIN UPPER † 1   
# participants affected / at risk   14/203 (6.90%) 
CONSTIPATION † 1   
# participants affected / at risk   34/203 (16.75%) 
DIARRHOEA † 1   
# participants affected / at risk   55/203 (27.09%) 
NAUSEA † 1   
# participants affected / at risk   68/203 (33.50%) 
STOMATITIS † 1   
# participants affected / at risk   15/203 (7.39%) 
VOMITING † 1   
# participants affected / at risk   53/203 (26.11%) 
General disorders   
ASTHENIA † 1   
# participants affected / at risk   19/203 (9.36%) 
FATIGUE † 1   
# participants affected / at risk   71/203 (34.98%) 
OEDEMA PERIPHERAL † 1   
# participants affected / at risk   26/203 (12.81%) 
PYREXIA † 1   
# participants affected / at risk   19/203 (9.36%) 
Infections and infestations   
PARONYCHIA † 1   
# participants affected / at risk   42/203 (20.69%) 
RASH PUSTULAR † 1   
# participants affected / at risk   18/203 (8.87%) 
UPPER RESPIRATORY TRACT INFECTION † 1   
# participants affected / at risk   11/203 (5.42%) 
Investigations   
WEIGHT DECREASED † 1   
# participants affected / at risk   24/203 (11.82%) 
Metabolism and nutrition disorders   
ANOREXIA † 1   
# participants affected / at risk   44/203 (21.67%) 
DEHYDRATION † 1   
# participants affected / at risk   13/203 (6.40%) 
HYPOCALCAEMIA † 1   
# participants affected / at risk   11/203 (5.42%) 
HYPOKALAEMIA † 1   
# participants affected / at risk   14/203 (6.90%) 
HYPOMAGNESAEMIA † 1   
# participants affected / at risk   28/203 (13.79%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA † 1   
# participants affected / at risk   15/203 (7.39%) 
BACK PAIN † 1   
# participants affected / at risk   21/203 (10.34%) 
Nervous system disorders   
DIZZINESS † 1   
# participants affected / at risk   14/203 (6.90%) 
HEADACHE † 1   
# participants affected / at risk   18/203 (8.87%) 
NEUROPATHY PERIPHERAL † 1   
# participants affected / at risk   11/203 (5.42%) 
Psychiatric disorders   
ANXIETY † 1   
# participants affected / at risk   14/203 (6.90%) 
DEPRESSION † 1   
# participants affected / at risk   11/203 (5.42%) 
INSOMNIA † 1   
# participants affected / at risk   19/203 (9.36%) 
Respiratory, thoracic and mediastinal disorders   
COUGH † 1   
# participants affected / at risk   28/203 (13.79%) 
DYSPNOEA † 1   
# participants affected / at risk   33/203 (16.26%) 
Skin and subcutaneous tissue disorders   
ACNE † 1   
# participants affected / at risk   11/203 (5.42%) 
DERMATITIS ACNEIFORM † 1   
# participants affected / at risk   141/203 (69.46%) 
DRY SKIN † 1   
# participants affected / at risk   41/203 (20.20%) 
ERYTHEMA † 1   
# participants affected / at risk   137/203 (67.49%) 
EXFOLIATIVE RASH † 1   
# participants affected / at risk   48/203 (23.65%) 
NAIL DISORDER † 1   
# participants affected / at risk   12/203 (5.91%) 
PRURITUS † 1   
# participants affected / at risk   140/203 (68.97%) 
RASH † 1   
# participants affected / at risk   59/203 (29.06%) 
RASH PAPULAR † 1   
# participants affected / at risk   14/203 (6.90%) 
SKIN EXFOLIATION † 1   
# participants affected / at risk   23/203 (11.33%) 
SKIN FISSURES † 1   
# participants affected / at risk   31/203 (15.27%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0



  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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  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



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