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
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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  
Blood and lymphatic system disorders    
ANAEMIA † 1  
# participants affected / at risk     14/203 (6.90%)  
Anaemia † 1  
# participants affected / at risk     14/203 (6.90%)  
Eye disorders    
CONJUNCTIVITIS † 1  
# participants affected / at risk     11/203 (5.42%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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
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