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Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617734
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Biological: IMC-A12 (cixutumumab)
Biological: cetuximab (Erbitux ®)
Enrollment 97
Recruitment Details  
Pre-assignment Details Presented are the reasons the participants discontinued from the study treatment.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as an intravenous (IV) infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy. (4-week cycle). Treatment was continued until there was evidence of progressive disease (PD), unacceptable toxicity, or withdrawal of consent. IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 milligrams per square meter (mg/m^2) administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Period Title: Overall Study
Started 49 48
Received at Least 1 Dose of Study Drug 47 44
Completed 41 42
Not Completed 8 6
Reason Not Completed
Withdrew Consent             2             0
Adverse Event             4             1
Protocol Violation             1             0
Found Ineligible After Randomization             1             4
Lost to Follow-up             0             1
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab Total
Hide Arm/Group Description IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. Total of all reporting groups
Overall Number of Baseline Participants 47 44 91
Hide Baseline Analysis Population Description
Randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants 44 participants 91 participants
60.0
(46.0 to 81.0)
59.0
(35.0 to 76.0)
60.0
(35.0 to 81.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Female
11
  23.4%
7
  15.9%
18
  19.8%
Male
36
  76.6%
37
  84.1%
73
  80.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Hispanic or Latino
1
   2.1%
4
   9.1%
5
   5.5%
Not Hispanic or Latino
46
  97.9%
40
  90.9%
86
  94.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
White
42
  89.4%
34
  77.3%
76
  83.5%
Black or African American
3
   6.4%
5
  11.4%
8
   8.8%
Asian
0
   0.0%
2
   4.5%
2
   2.2%
Other
2
   4.3%
3
   6.8%
5
   5.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 47 participants 44 participants 91 participants
47
 100.0%
44
 100.0%
91
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 47 participants 44 participants 91 participants
171.7  (10.53) 173.3  (9.56) 172.5  (10.05)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 47 participants 44 participants 91 participants
70.5  (13.68) 70.9  (18.19) 70.7  (15.93)
Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Square meters (m^2)
Number Analyzed 47 participants 44 participants 91 participants
1.80  (0.241) 1.82  (0.269) 1.81  (0.254)
[1]
Measure Description:

BSA is the measured or calculated surface area of a human body based on body weight and height.

The Mosteller¹ formula to calculate BSA (m^2) = ([Height (centimeter) x Weight (kilograms)]/ 3600)½.

Electrocardiogram (ECG)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Normal 20 26 46
Abnormal 27 18 45
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
0 = Fully Active 8 8 16
1 = Ambulatory, Restricted Work Activity 29 28 57
2 = Ambulatory, No Work Activity 10 8 18
[1]
Measure Description: ECOG performance status was used to classify participants according to their functional impairment. Score 0 = Fully active, able to carry on all pre-disease performance without restriction. Score 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work. Score 2 = Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.
Time Frame Baseline to measured PD (up to 27.66 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug. Seven (7) participants in IMC-A12 (Cixutumumab) and 4 participants in IMC-A12 (Cixutumumab) + Cetuximab were censored for analysis.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 47 44
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.6 to 1.9)
2.0
(1.8 to 3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMC-A12 (Cixutumumab), IMC-A12 (Cixutumumab) + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0667
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Hide Description ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.
Time Frame Baseline to measured PD (up to 27.66 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 47 44
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
2.1
(0.1 to 9.7)
9.1
(3.2 to 19.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMC-A12 (Cixutumumab), IMC-A12 (Cixutumumab) + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1935
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With PFS at 6 Months
Hide Description PFS at 6 months was defined as the percentage of participants who have neither experienced PD nor died at 6 months after the date of randomization. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 6 months divided by the total number of participants treated then multiplied by 100.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 47 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(0.5 to 14.5)
13.6
(5.2 to 27.4)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.
Time Frame Baseline to date of death from any cause (up to 29.63 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug. Eleven (11) participants in IMC-A12 (Cixutumumab) group and 6 participants in IMC-A12 (Cixutumumab) + Cetuximab group were censored for analysis.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 47 44
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(4.3 to 8.0)
5.5
(4.3 to 7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMC-A12 (Cixutumumab), IMC-A12 (Cixutumumab) + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7455
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response
Hide Description The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of PD or death. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of PD.
Time Frame Date of first response to the date of PD or death due to any cause (up to 23.98 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 1 4
Median (95% Confidence Interval)
Unit of Measure: months
12.8 [1] 
(NA to NA)
6.2
(3.58 to 23.98)
[1]
95% confidence interval was not estimable as only one participant had response.
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Hide Description TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs including serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events section of this report.
Time Frame Baseline through study completion (up to 29.63 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 47 44
Measure Type: Number
Unit of Measure: participants
TEAEs 47 44
Serious TEAEs 20 23
Death due to AEs 2 6
7.Secondary Outcome
Title Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab
Hide Description No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.
Time Frame Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up]
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to lack of an appropriate validated assay.
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description:
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Hide Arm/Group Description IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
All-Cause Mortality
IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/47 (42.55%)      23/44 (52.27%)    
Blood and lymphatic system disorders     
Anaemia  1  2/47 (4.26%)  2 0/44 (0.00%)  0
Leukocytosis  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Thrombocytopenia  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Cardiac disorders     
Atrial fibrillation  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Cardiac tamponade  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Left ventricular dysfunction  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Myocardial infarction  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Pericardial effusion  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Sick sinus syndrome  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Eye disorders     
Scotoma  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Constipation  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Dysphagia  1  2/47 (4.26%)  2 2/44 (4.55%)  2
Intestinal perforation  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Nausea  1  1/47 (2.13%)  2 4/44 (9.09%)  6
Oral cavity fistula  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Vomiting  1  1/47 (2.13%)  1 4/44 (9.09%)  6
General disorders     
Asthenia  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Disease progression  1  2/47 (4.26%)  2 3/44 (6.82%)  3
Facial pain  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Fatigue  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Infusion related reaction  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Pyrexia  1  3/47 (6.38%)  3 0/44 (0.00%)  0
Infections and infestations     
Biliary sepsis  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Clostridial infection  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Diverticulitis  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Enterococcal bacteraemia  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Infection  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Pneumonia  1  3/47 (6.38%)  3 3/44 (6.82%)  3
Pneumonia klebsiella  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Staphylococcal infection  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Urinary tract infection  1  2/47 (4.26%)  2 1/44 (2.27%)  1
Wound infection  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Injury, poisoning and procedural complications     
Overdose  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Dehydration  1  5/47 (10.64%)  6 6/44 (13.64%)  7
Hypercalcaemia  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Hyperglycaemia  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neck pain  1  2/47 (4.26%)  2 1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/47 (2.13%)  2 0/44 (0.00%)  0
Metastases to central nervous system  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Nervous system disorders     
Convulsion  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Dizziness  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Peripheral motor neuropathy  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Somnolence  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Syncope  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Psychiatric disorders     
Confusional state  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Delirium  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Depression  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Panic disorder  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/47 (0.00%)  0 2/44 (4.55%)  2
Hydropneumothorax  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Pharyngeal haemorrhage  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Pleural effusion  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Pneumonia aspiration  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Pneumonitis  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Stridor  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Upper airway obstruction  1  2/47 (4.26%)  2 0/44 (0.00%)  0
Surgical and medical procedures     
Gastrostomy tube insertion  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Vascular disorders     
Haemorrhage  1  1/47 (2.13%)  1 0/44 (0.00%)  0
Hypertension  1  1/47 (2.13%)  1 1/44 (2.27%)  1
Orthostatic hypotension  1  0/47 (0.00%)  0 1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMC-A12 (Cixutumumab) IMC-A12 (Cixutumumab) + Cetuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/47 (93.62%)      44/44 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  2/47 (4.26%)  2 4/44 (9.09%)  5
Ear and labyrinth disorders     
Ear pain  1  0/47 (0.00%)  0 5/44 (11.36%)  6
Eye disorders     
Dry eye  1  3/47 (6.38%)  3 2/44 (4.55%)  2
Gastrointestinal disorders     
Breath odour  1  3/47 (6.38%)  3 0/44 (0.00%)  0
Constipation  1  5/47 (10.64%)  5 8/44 (18.18%)  8
Diarrhoea  1  5/47 (10.64%)  7 9/44 (20.45%)  14
Dry mouth  1  4/47 (8.51%)  4 5/44 (11.36%)  5
Dyspepsia  1  2/47 (4.26%)  2 3/44 (6.82%)  3
Dysphagia  1  6/47 (12.77%)  6 5/44 (11.36%)  5
Nausea  1  13/47 (27.66%)  16 13/44 (29.55%)  17
Oral pain  1  4/47 (8.51%)  4 6/44 (13.64%)  8
Salivary gland disorder  1  3/47 (6.38%)  3 2/44 (4.55%)  3
Stomatitis  1  3/47 (6.38%)  4 13/44 (29.55%)  18
Vomiting  1  9/47 (19.15%)  10 7/44 (15.91%)  11
General disorders     
Fatigue  1  26/47 (55.32%)  35 27/44 (61.36%)  35
Oedema  1  3/47 (6.38%)  3 1/44 (2.27%)  1
Pyrexia  1  3/47 (6.38%)  3 7/44 (15.91%)  8
Infections and infestations     
Candidiasis  1  3/47 (6.38%)  3 3/44 (6.82%)  7
Localised infection  1  0/47 (0.00%)  0 3/44 (6.82%)  6
Oral infection  1  3/47 (6.38%)  3 1/44 (2.27%)  1
Paronychia  1  0/47 (0.00%)  0 8/44 (18.18%)  10
Injury, poisoning and procedural complications     
Contusion  1  3/47 (6.38%)  4 3/44 (6.82%)  3
Investigations     
Weight decreased  1  12/47 (25.53%)  13 13/44 (29.55%)  18
Metabolism and nutrition disorders     
Decreased appetite  1  8/47 (17.02%)  8 8/44 (18.18%)  11
Dehydration  1  1/47 (2.13%)  1 3/44 (6.82%)  3
Hyperglycaemia  1  12/47 (25.53%)  16 13/44 (29.55%)  20
Hypokalaemia  1  2/47 (4.26%)  2 3/44 (6.82%)  3
Hypomagnesaemia  1  4/47 (8.51%)  5 10/44 (22.73%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/47 (0.00%)  0 3/44 (6.82%)  3
Back pain  1  3/47 (6.38%)  5 2/44 (4.55%)  2
Musculoskeletal pain  1  4/47 (8.51%)  5 1/44 (2.27%)  2
Myalgia  1  3/47 (6.38%)  4 3/44 (6.82%)  4
Neck pain  1  4/47 (8.51%)  4 4/44 (9.09%)  5
Pain in extremity  1  1/47 (2.13%)  1 5/44 (11.36%)  5
Pain in jaw  1  2/47 (4.26%)  3 3/44 (6.82%)  3
Nervous system disorders     
Dizziness  1  3/47 (6.38%)  3 6/44 (13.64%)  8
Dysarthria  1  1/47 (2.13%)  1 3/44 (6.82%)  3
Dysgeusia  1  1/47 (2.13%)  1 4/44 (9.09%)  4
Headache  1  8/47 (17.02%)  9 11/44 (25.00%)  11
Psychiatric disorders     
Depression  1  3/47 (6.38%)  3 1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/47 (8.51%)  5 4/44 (9.09%)  4
Dyspnoea  1  6/47 (12.77%)  6 6/44 (13.64%)  8
Haemoptysis  1  4/47 (8.51%)  4 1/44 (2.27%)  1
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  3/47 (6.38%)  3 28/44 (63.64%)  46
Dry skin  1  1/47 (2.13%)  1 5/44 (11.36%)  6
Erythema  1  1/47 (2.13%)  1 3/44 (6.82%)  4
Nail disorder  1  2/47 (4.26%)  2 7/44 (15.91%)  10
Pruritus  1  4/47 (8.51%)  4 7/44 (15.91%)  8
Rash macular  1  0/47 (0.00%)  0 3/44 (6.82%)  4
Skin disorder  1  1/47 (2.13%)  1 5/44 (11.36%)  8
Skin fissures  1  0/47 (0.00%)  0 3/44 (6.82%)  5
Vascular disorders     
Haemorrhage  1  3/47 (6.38%)  5 2/44 (4.55%)  2
Hypotension  1  2/47 (4.26%)  2 7/44 (15.91%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00617734    
Other Study ID Numbers: 13913
CP13-0706 ( Other Identifier: ImClone, LLC )
CP02-0758 ( Other Identifier: ImClone, LLC )
I5A-IE-JAEB ( Other Identifier: Eli Lilly and Company )
First Submitted: January 30, 2008
First Posted: February 18, 2008
Results First Submitted: March 17, 2018
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018