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ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01001377
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : March 24, 2014
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Cetuximab
Drug: Panitumumab
Enrollment 1010
Recruitment Details

First patient enrolled on 2nd February 2010 and last patient enrolled 19 July 2012.

Results are reported as of the data cut-off date of 5 February 2013.
Pre-assignment Details  
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
Period Title: Overall Study
Started 504 506
Received Treatment 500 499
Completed 78 [1] 85 [1]
Not Completed 426 421
Reason Not Completed
Ineligibility determined             2             0
Withdrawal by Subject             19             20
Lost to Follow-up             14             17
Death             391             384
[1]
Indicates participants continuing in study
Arm/Group Title Cetuximab Panitumumab Total
Hide Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days. Total of all reporting groups
Overall Number of Baseline Participants 504 506 1010
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 504 participants 506 participants 1010 participants
60.2  (11.2) 59.6  (10.9) 59.9  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 504 participants 506 participants 1010 participants
Female
183
  36.3%
187
  37.0%
370
  36.6%
Male
321
  63.7%
319
  63.0%
640
  63.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 504 participants 506 participants 1010 participants
Asian 230 225 455
Black or African American 4 2 6
Hispanic or Latino 7 6 13
Japanese 0 1 1
Other 3 2 5
White or Caucasian 260 270 530
Geographic region   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 504 participants 506 participants 1010 participants
North America, Western Europe and Australia 158 158 316
Rest of World 346 348 694
[1]
Measure Description: Stratification factor. Rest of world includes South America, Asia and South Africa
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 504 participants 506 participants 1010 participants
Grade 0 165 155 320
Grade 1 299 309 608
Grade 2 40 42 82
[1]
Measure Description:

0 = Fully active, able to carry on all pre-disease performance without restriction.

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, ie, light housework or office work.
  2. = Ambulatory and capable of all self-care but unable to carry out any work. activities. Up and about > 50% of waking hours.
  3. = Capable of only limited self-care, confined to a bed or chair > 50% of waking hours.
  4. = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
  5. = Dead.
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 500 499
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(9.3 to 11.0)
10.4
(9.4 to 11.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Cox proportional hazard ratio
Estimated Value 0.966
Confidence Interval (2-Sided) 95%
0.839 to 1.113
Estimation Comments Hazard ratio is presented as panitumumab : cetuximab. A value < 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value < -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.
Statistical Test of Hypothesis P-Value 0.0007
Comments A synthesis approach with an asymptotic standard normal test statistic
Method Asymptotic standard normal test
Comments [Not Specified]
Method of Estimation Estimation Parameter Normal score
Estimated Value -3.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.

Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 500 499
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(3.2 to 4.8)
4.1
(3.2 to 4.8)
3.Secondary Outcome
Title Objective Response
Hide Description Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 485 486
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.79
(16.34 to 23.62)
22.02
(18.41 to 25.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.83 to 1.58
Estimation Comments Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an objective response
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 96 107
Median (95% Confidence Interval)
Unit of Measure: months
5.4
(3.8 to 5.5)
3.8
(3.7 to 4.8)
5.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an objective response
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 96 107
Median (Inter-Quartile Range)
Unit of Measure: months
2.6
(1.2 to 3.1)
1.5
(1.2 to 3.0)
6.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.
Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 500 499
Median (95% Confidence Interval)
Unit of Measure: months
3.3
(3.2 to 3.9)
3.4
(3.2 to 4.6)
7.Secondary Outcome
Title Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
Hide Description The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 150 143
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
-0.0341
(-0.0806 to 0.0123)
-0.0216
(-0.0691 to 0.0260)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0126
Confidence Interval (2-Sided) 95%
-0.0353 to 0.0605
Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
8.Secondary Outcome
Title Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
Hide Description The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) analysis set participants with available data
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 149 142
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
3.9782
(0.8842 to 7.0722)
2.3037
(-0.8532 to 5.4605)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6745
Confidence Interval (2-Sided) 95%
-4.9331 to 1.5841
Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
9.Secondary Outcome
Title Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score
Hide Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) analysis set participants with available data.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 151 142
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
2.0101
(-1.1477 to 5.1679)
3.0473
(-0.1782 to 6.2728)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.0372
Confidence Interval (2-Sided) 95%
-2.3267 to 4.4010
Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
10.Secondary Outcome
Title Change From Baseline in NCCN FCSI Physical Well-being Scale Score
Hide Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) analysis set participants with available data.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
1.8778
(-1.5524 to 5.3080)
2.4614
(-1.0442 to 5.9670)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5836
Confidence Interval (2-Sided) 95%
-3.0269 to 4.1941
Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
11.Secondary Outcome
Title Change From Baseline in NCCN FCSI Functional Well-being Scale Score
Hide Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) analysis set participants with available data.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 152 143
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
1.3567
(-4.1564 to 6.8697)
1.1569
(-4.4887 to 6.8025)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1998
Confidence Interval (2-Sided) 95%
-6.0093 to 5.6098
Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
Time Frame From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description:
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Panitumumab 6 mg/kg IV every 14 days.
Overall Number of Participants Analyzed 503 496
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 494 485
Serious adverse events 169 151
Leading to discontinuation of study drug 61 69
Any treatment-related adverse event (TRAE) 459 437
Treatment-related serious adverse event 22 25
TRAE leading to discontinuation of study drug 15 14
Time Frame Median time was 117 days for panitumumab arm and 123 days for cetuximab arm.
Adverse Event Reporting Description

Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Cetuximab Panitumumab
Hide Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
All-Cause Mortality
Cetuximab Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cetuximab Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   169/503 (33.60%)   151/496 (30.44%) 
Blood and lymphatic system disorders     
Anaemia † 1  3/503 (0.60%)  6/496 (1.21%) 
Disseminated intravascular coagulation † 1  0/503 (0.00%)  1/496 (0.20%) 
Cardiac disorders     
Atrial fibrillation † 1  1/503 (0.20%)  1/496 (0.20%) 
Cardiac arrest † 1  0/503 (0.00%)  1/496 (0.20%) 
Cardiac failure congestive † 1  1/503 (0.20%)  0/496 (0.00%) 
Cardiomyopathy † 1  1/503 (0.20%)  0/496 (0.00%) 
Cardiopulmonary failure † 1  1/503 (0.20%)  0/496 (0.00%) 
Cardiovascular insufficiency † 1  1/503 (0.20%)  0/496 (0.00%) 
Myocardial infarction † 1  0/503 (0.00%)  1/496 (0.20%) 
Myocardial ischaemia † 1  1/503 (0.20%)  0/496 (0.00%) 
Tachycardia † 1  0/503 (0.00%)  1/496 (0.20%) 
Gastrointestinal disorders     
Abdominal distension † 1  4/503 (0.80%)  0/496 (0.00%) 
Abdominal mass † 1  1/503 (0.20%)  0/496 (0.00%) 
Abdominal pain † 1  13/503 (2.58%)  10/496 (2.02%) 
Abdominal pain lower † 1  1/503 (0.20%)  0/496 (0.00%) 
Abdominal pain upper † 1  2/503 (0.40%)  3/496 (0.60%) 
Ascites † 1  5/503 (0.99%)  5/496 (1.01%) 
Colitis † 1  2/503 (0.40%)  0/496 (0.00%) 
Constipation † 1  3/503 (0.60%)  2/496 (0.40%) 
Diarrhoea † 1  8/503 (1.59%)  6/496 (1.21%) 
Duodenal obstruction † 1  1/503 (0.20%)  0/496 (0.00%) 
Duodenal ulcer † 1  1/503 (0.20%)  0/496 (0.00%) 
Dyspepsia † 1  1/503 (0.20%)  0/496 (0.00%) 
Dysphagia † 1  0/503 (0.00%)  1/496 (0.20%) 
Enteritis † 1  0/503 (0.00%)  1/496 (0.20%) 
Faecaloma † 1  0/503 (0.00%)  1/496 (0.20%) 
Gastritis † 1  1/503 (0.20%)  1/496 (0.20%) 
Gastrointestinal haemorrhage † 1  1/503 (0.20%)  2/496 (0.40%) 
Gastrointestinal obstruction † 1  0/503 (0.00%)  1/496 (0.20%) 
Gastrooesophageal reflux disease † 1  1/503 (0.20%)  0/496 (0.00%) 
Haematochezia † 1  1/503 (0.20%)  0/496 (0.00%) 
Ileus † 1  5/503 (0.99%)  5/496 (1.01%) 
Intestinal infarction † 1  0/503 (0.00%)  1/496 (0.20%) 
Intestinal obstruction † 1  8/503 (1.59%)  12/496 (2.42%) 
Intestinal perforation † 1  0/503 (0.00%)  1/496 (0.20%) 
Large intestinal obstruction † 1  0/503 (0.00%)  1/496 (0.20%) 
Large intestine perforation † 1  0/503 (0.00%)  2/496 (0.40%) 
Lower gastrointestinal haemorrhage † 1  1/503 (0.20%)  0/496 (0.00%) 
Melaena † 1  1/503 (0.20%)  0/496 (0.00%) 
Mesenteric vein thrombosis † 1  0/503 (0.00%)  1/496 (0.20%) 
Nausea † 1  5/503 (0.99%)  2/496 (0.40%) 
Obturator hernia † 1  0/503 (0.00%)  1/496 (0.20%) 
Pancreatitis acute † 1  1/503 (0.20%)  0/496 (0.00%) 
Peritoneal adhesions † 1  1/503 (0.20%)  0/496 (0.00%) 
Proctalgia † 1  0/503 (0.00%)  1/496 (0.20%) 
Rectal haemorrhage † 1  0/503 (0.00%)  1/496 (0.20%) 
Rectal polyp † 1  1/503 (0.20%)  0/496 (0.00%) 
Rectal tenesmus † 1  0/503 (0.00%)  1/496 (0.20%) 
Small intestinal obstruction † 1  3/503 (0.60%)  4/496 (0.81%) 
Small intestinal perforation † 1  1/503 (0.20%)  0/496 (0.00%) 
Stomatitis † 1  0/503 (0.00%)  1/496 (0.20%) 
Subileus † 1  1/503 (0.20%)  2/496 (0.40%) 
Vomiting † 1  5/503 (0.99%)  12/496 (2.42%) 
General disorders     
Asthenia † 1  4/503 (0.80%)  6/496 (1.21%) 
Chest discomfort † 1  1/503 (0.20%)  1/496 (0.20%) 
Chest pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Death † 1  1/503 (0.20%)  0/496 (0.00%) 
Device occlusion † 1  0/503 (0.00%)  2/496 (0.40%) 
Fatigue † 1  4/503 (0.80%)  4/496 (0.81%) 
Gait disturbance † 1  0/503 (0.00%)  1/496 (0.20%) 
General physical health deterioration † 1  2/503 (0.40%)  1/496 (0.20%) 
Hyperpyrexia † 1  0/503 (0.00%)  1/496 (0.20%) 
Malaise † 1  0/503 (0.00%)  1/496 (0.20%) 
Multi-organ failure † 1  1/503 (0.20%)  0/496 (0.00%) 
Non-cardiac chest pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Oedema † 1  1/503 (0.20%)  0/496 (0.00%) 
Oedema peripheral † 1  2/503 (0.40%)  1/496 (0.20%) 
Pain † 1  1/503 (0.20%)  0/496 (0.00%) 
Performance status decreased † 1  1/503 (0.20%)  1/496 (0.20%) 
Pyrexia † 1  8/503 (1.59%)  3/496 (0.60%) 
Systemic inflammatory response syndrome † 1  0/503 (0.00%)  1/496 (0.20%) 
Hepatobiliary disorders     
Bile duct obstruction † 1  2/503 (0.40%)  1/496 (0.20%) 
Cholangitis † 1  0/503 (0.00%)  1/496 (0.20%) 
Cholecystitis † 1  1/503 (0.20%)  0/496 (0.00%) 
Cholestasis † 1  0/503 (0.00%)  1/496 (0.20%) 
Hepatic failure † 1  2/503 (0.40%)  1/496 (0.20%) 
Hepatic function abnormal † 1  4/503 (0.80%)  2/496 (0.40%) 
Hepatic lesion † 1  1/503 (0.20%)  0/496 (0.00%) 
Hepatocellular injury † 1  0/503 (0.00%)  1/496 (0.20%) 
Hyperbilirubinaemia † 1  4/503 (0.80%)  1/496 (0.20%) 
Jaundice † 1  0/503 (0.00%)  3/496 (0.60%) 
Jaundice cholestatic † 1  2/503 (0.40%)  0/496 (0.00%) 
Jaundice extrahepatic obstructive † 1  1/503 (0.20%)  0/496 (0.00%) 
Immune system disorders     
Anaphylactic reaction † 1  3/503 (0.60%)  0/496 (0.00%) 
Cytokine release syndrome † 1  1/503 (0.20%)  0/496 (0.00%) 
Hypersensitivity † 1  2/503 (0.40%)  1/496 (0.20%) 
Infections and infestations     
Abdominal abscess † 1  1/503 (0.20%)  0/496 (0.00%) 
Abscess limb † 1  1/503 (0.20%)  0/496 (0.00%) 
Anal abscess † 1  0/503 (0.00%)  1/496 (0.20%) 
Bacteraemia † 1  1/503 (0.20%)  0/496 (0.00%) 
Bronchopneumonia † 1  1/503 (0.20%)  0/496 (0.00%) 
Cellulitis † 1  1/503 (0.20%)  2/496 (0.40%) 
Cystitis † 1  0/503 (0.00%)  1/496 (0.20%) 
Device related infection † 1  1/503 (0.20%)  2/496 (0.40%) 
Device related sepsis † 1  1/503 (0.20%)  0/496 (0.00%) 
Enterococcal infection † 1  1/503 (0.20%)  0/496 (0.00%) 
Escherichia infection † 1  1/503 (0.20%)  0/496 (0.00%) 
Furuncle † 1  1/503 (0.20%)  0/496 (0.00%) 
Gastroenteritis † 1  1/503 (0.20%)  1/496 (0.20%) 
Gastroenteritis viral † 1  0/503 (0.00%)  1/496 (0.20%) 
Gastrointestinal infection † 1  1/503 (0.20%)  1/496 (0.20%) 
Herpes zoster † 1  1/503 (0.20%)  0/496 (0.00%) 
Infected dermal cyst † 1  0/503 (0.00%)  1/496 (0.20%) 
Infection † 1  1/503 (0.20%)  2/496 (0.40%) 
Lobar pneumonia † 1  0/503 (0.00%)  1/496 (0.20%) 
Lower respiratory tract infection † 1  2/503 (0.40%)  0/496 (0.00%) 
Lung infection † 1  2/503 (0.40%)  0/496 (0.00%) 
Nail infection † 1  0/503 (0.00%)  1/496 (0.20%) 
Neutropenic sepsis † 1  1/503 (0.20%)  0/496 (0.00%) 
Paronychia † 1  1/503 (0.20%)  0/496 (0.00%) 
Peritonitis † 1  0/503 (0.00%)  1/496 (0.20%) 
Pneumonia † 1  7/503 (1.39%)  2/496 (0.40%) 
Pyelonephritis acute † 1  1/503 (0.20%)  1/496 (0.20%) 
Pyonephrosis † 1  1/503 (0.20%)  0/496 (0.00%) 
Respiratory tract infection † 1  0/503 (0.00%)  1/496 (0.20%) 
Sepsis † 1  1/503 (0.20%)  5/496 (1.01%) 
Septic shock † 1  1/503 (0.20%)  0/496 (0.00%) 
Staphylococcal sepsis † 1  1/503 (0.20%)  0/496 (0.00%) 
Subcutaneous abscess † 1  0/503 (0.00%)  1/496 (0.20%) 
Tooth abscess † 1  0/503 (0.00%)  1/496 (0.20%) 
Upper respiratory tract infection † 1  0/503 (0.00%)  1/496 (0.20%) 
Urinary bladder abscess † 1  1/503 (0.20%)  0/496 (0.00%) 
Urinary tract infection † 1  7/503 (1.39%)  9/496 (1.81%) 
Urosepsis † 1  0/503 (0.00%)  1/496 (0.20%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture † 1  0/503 (0.00%)  1/496 (0.20%) 
Contusion † 1  0/503 (0.00%)  1/496 (0.20%) 
Fall † 1  0/503 (0.00%)  1/496 (0.20%) 
Fracture † 1  0/503 (0.00%)  1/496 (0.20%) 
Joint dislocation † 1  1/503 (0.20%)  0/496 (0.00%) 
Laceration † 1  0/503 (0.00%)  1/496 (0.20%) 
Poisoning † 1  1/503 (0.20%)  0/496 (0.00%) 
Scapula fracture † 1  0/503 (0.00%)  1/496 (0.20%) 
Soft tissue injury † 1  0/503 (0.00%)  1/496 (0.20%) 
Wound complication † 1  1/503 (0.20%)  0/496 (0.00%) 
Investigations     
Blood bilirubin increased † 1  2/503 (0.40%)  2/496 (0.40%) 
Blood creatine increased † 1  0/503 (0.00%)  1/496 (0.20%) 
Blood creatinine increased † 1  1/503 (0.20%)  1/496 (0.20%) 
Blood uric acid increased † 1  0/503 (0.00%)  1/496 (0.20%) 
Haemoglobin decreased † 1  0/503 (0.00%)  2/496 (0.40%) 
Red blood cell count decreased † 1  0/503 (0.00%)  1/496 (0.20%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  3/503 (0.60%)  0/496 (0.00%) 
Dehydration † 1  0/503 (0.00%)  2/496 (0.40%) 
Diabetes mellitus † 1  1/503 (0.20%)  1/496 (0.20%) 
Diabetes mellitus inadequate control † 1  1/503 (0.20%)  0/496 (0.00%) 
Fluid overload † 1  1/503 (0.20%)  0/496 (0.00%) 
Hypercalcaemia † 1  1/503 (0.20%)  1/496 (0.20%) 
Hyperkalaemia † 1  0/503 (0.00%)  4/496 (0.81%) 
Hyperuricaemia † 1  1/503 (0.20%)  0/496 (0.00%) 
Hypoalbuminaemia † 1  1/503 (0.20%)  0/496 (0.00%) 
Hypoglycaemia † 1  1/503 (0.20%)  0/496 (0.00%) 
Hypokalaemia † 1  0/503 (0.00%)  1/496 (0.20%) 
Hypomagnesaemia † 1  1/503 (0.20%)  3/496 (0.60%) 
Hyponatraemia † 1  0/503 (0.00%)  2/496 (0.40%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/503 (0.20%)  0/496 (0.00%) 
Back pain † 1  2/503 (0.40%)  4/496 (0.81%) 
Flank pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Groin pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Muscle haemorrhage † 1  1/503 (0.20%)  0/496 (0.00%) 
Muscular weakness † 1  1/503 (0.20%)  1/496 (0.20%) 
Musculoskeletal chest pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Musculoskeletal pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Pain in extremity † 1  0/503 (0.00%)  1/496 (0.20%) 
Pathological fracture † 1  1/503 (0.20%)  0/496 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer † 1  5/503 (0.99%)  5/496 (1.01%) 
Colon cancer metastatic † 1  6/503 (1.19%)  4/496 (0.81%) 
Colorectal cancer † 1  10/503 (1.99%)  7/496 (1.41%) 
Colorectal cancer metastatic † 1  14/503 (2.78%)  7/496 (1.41%) 
Infected neoplasm † 1  0/503 (0.00%)  1/496 (0.20%) 
Metastases to bone † 1  0/503 (0.00%)  2/496 (0.40%) 
Metastases to central nervous system † 1  2/503 (0.40%)  4/496 (0.81%) 
Metastases to liver † 1  2/503 (0.40%)  0/496 (0.00%) 
Metastases to meninges † 1  1/503 (0.20%)  0/496 (0.00%) 
Metastases to ovary † 1  1/503 (0.20%)  0/496 (0.00%) 
Metastases to spine † 1  0/503 (0.00%)  1/496 (0.20%) 
Rectal cancer † 1  2/503 (0.40%)  1/496 (0.20%) 
Tumour haemorrhage † 1  1/503 (0.20%)  0/496 (0.00%) 
Tumour necrosis † 1  0/503 (0.00%)  2/496 (0.40%) 
Tumour pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Tumour thrombosis † 1  0/503 (0.00%)  1/496 (0.20%) 
Nervous system disorders     
Altered state of consciousness † 1  0/503 (0.00%)  1/496 (0.20%) 
Carotid artery stenosis † 1  1/503 (0.20%)  0/496 (0.00%) 
Central nervous system lesion † 1  1/503 (0.20%)  0/496 (0.00%) 
Cerebral infarction † 1  2/503 (0.40%)  0/496 (0.00%) 
Cognitive disorder † 1  0/503 (0.00%)  1/496 (0.20%) 
Convulsion † 1  1/503 (0.20%)  0/496 (0.00%) 
Dizziness † 1  0/503 (0.00%)  1/496 (0.20%) 
Dyskinesia † 1  1/503 (0.20%)  0/496 (0.00%) 
Hemiparesis † 1  0/503 (0.00%)  1/496 (0.20%) 
Loss of consciousness † 1  1/503 (0.20%)  0/496 (0.00%) 
Spinal cord compression † 1  1/503 (0.20%)  0/496 (0.00%) 
Syncope † 1  0/503 (0.00%)  2/496 (0.40%) 
Psychiatric disorders     
Anxiety † 1  0/503 (0.00%)  1/496 (0.20%) 
Confusional state † 1  1/503 (0.20%)  2/496 (0.40%) 
Depression † 1  0/503 (0.00%)  1/496 (0.20%) 
Renal and urinary disorders     
Azotaemia † 1  2/503 (0.40%)  0/496 (0.00%) 
Bladder dilatation † 1  0/503 (0.00%)  1/496 (0.20%) 
Dysuria † 1  1/503 (0.20%)  1/496 (0.20%) 
Haematuria † 1  1/503 (0.20%)  1/496 (0.20%) 
Hydronephrosis † 1  2/503 (0.40%)  4/496 (0.81%) 
Obstructive uropathy † 1  1/503 (0.20%)  0/496 (0.00%) 
Oliguria † 1  0/503 (0.00%)  1/496 (0.20%) 
Renal failure † 1  1/503 (0.20%)  2/496 (0.40%) 
Renal failure acute † 1  1/503 (0.20%)  2/496 (0.40%) 
Renal failure chronic † 1  0/503 (0.00%)  1/496 (0.20%) 
Renal impairment † 1  1/503 (0.20%)  2/496 (0.40%) 
Ureteric stenosis † 1  1/503 (0.20%)  1/496 (0.20%) 
Urinary tract obstruction † 1  0/503 (0.00%)  1/496 (0.20%) 
Reproductive system and breast disorders     
Female genital tract fistula † 1  1/503 (0.20%)  0/496 (0.00%) 
Oedema genital † 1  0/503 (0.00%)  1/496 (0.20%) 
Pelvic pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Perineal pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure † 1  0/503 (0.00%)  1/496 (0.20%) 
Asthma † 1  0/503 (0.00%)  1/496 (0.20%) 
Dyspnoea † 1  6/503 (1.19%)  3/496 (0.60%) 
Epistaxis † 1  1/503 (0.20%)  0/496 (0.00%) 
Pleural effusion † 1  3/503 (0.60%)  1/496 (0.20%) 
Pleuritic pain † 1  0/503 (0.00%)  1/496 (0.20%) 
Pneumonia aspiration † 1  0/503 (0.00%)  1/496 (0.20%) 
Pneumothorax † 1  0/503 (0.00%)  1/496 (0.20%) 
Productive cough † 1  0/503 (0.00%)  1/496 (0.20%) 
Pulmonary embolism † 1  1/503 (0.20%)  2/496 (0.40%) 
Respiratory depression † 1  0/503 (0.00%)  1/496 (0.20%) 
Respiratory distress † 1  1/503 (0.20%)  0/496 (0.00%) 
Respiratory failure † 1  3/503 (0.60%)  0/496 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer † 1  0/503 (0.00%)  1/496 (0.20%) 
Surgical and medical procedures     
Central venous catheterisation † 1  0/503 (0.00%)  1/496 (0.20%) 
Salpingo-oophorectomy bilateral † 1  0/503 (0.00%)  1/496 (0.20%) 
Vascular disorders     
Artery dissection † 1  0/503 (0.00%)  1/496 (0.20%) 
Deep vein thrombosis † 1  1/503 (0.20%)  1/496 (0.20%) 
Embolism † 1  0/503 (0.00%)  1/496 (0.20%) 
Haemorrhage † 1  0/503 (0.00%)  1/496 (0.20%) 
Lymphocele † 1  1/503 (0.20%)  0/496 (0.00%) 
Superior vena cava syndrome † 1  2/503 (0.40%)  0/496 (0.00%) 
Thrombosis † 1  0/503 (0.00%)  1/496 (0.20%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab Panitumumab
Affected / at Risk (%) Affected / at Risk (%)
Total   474/503 (94.23%)   459/496 (92.54%) 
Blood and lymphatic system disorders     
Anaemia † 1  30/503 (5.96%)  29/496 (5.85%) 
Gastrointestinal disorders     
Abdominal pain † 1  74/503 (14.71%)  52/496 (10.48%) 
Constipation † 1  70/503 (13.92%)  39/496 (7.86%) 
Diarrhoea † 1  87/503 (17.30%)  88/496 (17.74%) 
Dyspepsia † 1  26/503 (5.17%)  19/496 (3.83%) 
Nausea † 1  56/503 (11.13%)  66/496 (13.31%) 
Stomatitis † 1  34/503 (6.76%)  26/496 (5.24%) 
Vomiting † 1  49/503 (9.74%)  49/496 (9.88%) 
General disorders     
Asthenia † 1  44/503 (8.75%)  30/496 (6.05%) 
Fatigue † 1  85/503 (16.90%)  72/496 (14.52%) 
Oedema peripheral † 1  38/503 (7.55%)  22/496 (4.44%) 
Pyrexia † 1  50/503 (9.94%)  28/496 (5.65%) 
Infections and infestations     
Paronychia † 1  75/503 (14.91%)  58/496 (11.69%) 
Upper respiratory tract infection † 1  28/503 (5.57%)  14/496 (2.82%) 
Investigations     
Weight decreased † 1  21/503 (4.17%)  26/496 (5.24%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  77/503 (15.31%)  69/496 (13.91%) 
Hypocalcaemia † 1  16/503 (3.18%)  26/496 (5.24%) 
Hypokalaemia † 1  23/503 (4.57%)  41/496 (8.27%) 
Hypomagnesaemia † 1  89/503 (17.69%)  134/496 (27.02%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  37/503 (7.36%)  34/496 (6.85%) 
Nervous system disorders     
Headache † 1  36/503 (7.16%)  17/496 (3.43%) 
Psychiatric disorders     
Insomnia † 1  46/503 (9.15%)  27/496 (5.44%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  38/503 (7.55%)  40/496 (8.06%) 
Dyspnoea † 1  33/503 (6.56%)  19/496 (3.83%) 
Skin and subcutaneous tissue disorders     
Acne † 1  69/503 (13.72%)  52/496 (10.48%) 
Dermatitis acneiform † 1  136/503 (27.04%)  138/496 (27.82%) 
Dry skin † 1  79/503 (15.71%)  83/496 (16.73%) 
Nail disorder † 1  31/503 (6.16%)  26/496 (5.24%) 
Pruritus † 1  88/503 (17.50%)  83/496 (16.73%) 
Rash † 1  257/503 (51.09%)  249/496 (50.20%) 
Skin fissures † 1  43/503 (8.55%)  42/496 (8.47%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[Not Specified]
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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01001377    
Other Study ID Numbers: 20080763
ASPECCT
2009-010715-32 ( EudraCT Number )
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: February 3, 2014
Results First Posted: March 24, 2014
Last Update Posted: September 21, 2022