Trial Outcomes & Findings for 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 (NCT NCT00617734)
NCT ID: NCT00617734
Last Updated: 2018-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Baseline to measured PD (up to 27.66 months)
Results posted on
2018-04-17
Participant Flow
Presented are the reasons the participants discontinued from the study treatment.
Participant milestones
| Measure |
IMC-A12 (Cixutumumab)
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) + Cetuximab
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
47
|
44
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
IMC-A12 (Cixutumumab)
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) + Cetuximab
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.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
2
|
0
|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Found Ineligible After Randomization
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=5 Participants
|
59.0 years
n=7 Participants
|
60.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Height
|
171.7 centimeters (cm)
STANDARD_DEVIATION 10.53 • n=5 Participants
|
173.3 centimeters (cm)
STANDARD_DEVIATION 9.56 • n=7 Participants
|
172.5 centimeters (cm)
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Weight
|
70.5 kilograms (kg)
STANDARD_DEVIATION 13.68 • n=5 Participants
|
70.9 kilograms (kg)
STANDARD_DEVIATION 18.19 • n=7 Participants
|
70.7 kilograms (kg)
STANDARD_DEVIATION 15.93 • n=5 Participants
|
|
Body Surface Area (BSA)
|
1.80 square meters (m^2)
STANDARD_DEVIATION 0.241 • n=5 Participants
|
1.82 square meters (m^2)
STANDARD_DEVIATION 0.269 • n=7 Participants
|
1.81 square meters (m^2)
STANDARD_DEVIATION 0.254 • n=5 Participants
|
|
Electrocardiogram (ECG)
Normal
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Electrocardiogram (ECG)
Abnormal
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
0 = Fully Active
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
1 = Ambulatory, Restricted Work Activity
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
2 = Ambulatory, No Work Activity
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured PD (up to 27.66 months)Population: 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.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
1.9 months
Interval 1.6 to 1.9
|
2.0 months
Interval 1.8 to 3.5
|
SECONDARY outcome
Timeframe: Baseline to measured PD (up to 27.66 months)Population: Randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
|
2.1 percentage of participants
Interval 0.1 to 9.7
|
9.1 percentage of participants
Interval 3.2 to 19.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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.
|
|---|---|---|
|
Percentage of Participants With PFS at 6 Months
|
4.3 percentage of participants
Interval 0.5 to 14.5
|
13.6 percentage of participants
Interval 5.2 to 27.4
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause (up to 29.63 months)Population: 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.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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 Survival (OS)
|
5.3 months
Interval 4.3 to 8.0
|
5.5 months
Interval 4.3 to 7.4
|
SECONDARY outcome
Timeframe: Date of first response to the date of PD or death due to any cause (up to 23.98 months)Population: Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=1 Participants
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) + Cetuximab
n=4 Participants
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.
|
|---|---|---|
|
Duration of Response
|
12.8 months
95% confidence interval was not estimable as only one participant had response.
|
6.2 months
Interval 3.58 to 23.98
|
SECONDARY outcome
Timeframe: Baseline through study completion (up to 29.63 months)Population: Randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
IMC-A12 (Cixutumumab)
n=47 Participants
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) + Cetuximab
n=44 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
TEAEs
|
47 participants
|
44 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Serious TEAEs
|
20 participants
|
23 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Death due to AEs
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 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]Population: No participants were analyzed due to lack of an appropriate validated assay.
No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.
Outcome measures
Outcome data not reported
Adverse Events
IMC-A12 (Cixutumumab)
Serious events: 20 serious events
Other events: 44 other events
Deaths: 0 deaths
IMC-A12 (Cixutumumab) + Cetuximab
Serious events: 23 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMC-A12 (Cixutumumab)
n=47 participants at risk
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) + Cetuximab
n=44 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
2/47 • Number of events 2
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Scotoma
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
2/47 • Number of events 2
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/47 • Number of events 2
|
9.1%
4/44 • Number of events 6
|
|
Gastrointestinal disorders
Oral cavity fistula
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1
|
9.1%
4/44 • Number of events 6
|
|
General disorders
Asthenia
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Disease progression
|
4.3%
2/47 • Number of events 2
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Facial pain
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Fatigue
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pyrexia
|
6.4%
3/47 • Number of events 3
|
0.00%
0/44
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Infection
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.4%
3/47 • Number of events 3
|
6.8%
3/44 • Number of events 3
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/47 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Wound infection
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
10.6%
5/47 • Number of events 6
|
13.6%
6/44 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
2/47 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.1%
1/47 • Number of events 2
|
0.00%
0/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Psychiatric disorders
Delirium
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Psychiatric disorders
Depression
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Psychiatric disorders
Panic disorder
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
4.3%
2/47 • Number of events 2
|
0.00%
0/44
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Vascular disorders
Haemorrhage
|
2.1%
1/47 • Number of events 1
|
0.00%
0/44
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/47
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
IMC-A12 (Cixutumumab)
n=47 participants at risk
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) + Cetuximab
n=44 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
2/47 • Number of events 2
|
9.1%
4/44 • Number of events 5
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/47
|
11.4%
5/44 • Number of events 6
|
|
Eye disorders
Dry eye
|
6.4%
3/47 • Number of events 3
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Breath odour
|
6.4%
3/47 • Number of events 3
|
0.00%
0/44
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Number of events 5
|
18.2%
8/44 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
5/47 • Number of events 7
|
20.5%
9/44 • Number of events 14
|
|
Gastrointestinal disorders
Dry mouth
|
8.5%
4/47 • Number of events 4
|
11.4%
5/44 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47 • Number of events 2
|
6.8%
3/44 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
12.8%
6/47 • Number of events 6
|
11.4%
5/44 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
27.7%
13/47 • Number of events 16
|
29.5%
13/44 • Number of events 17
|
|
Gastrointestinal disorders
Oral pain
|
8.5%
4/47 • Number of events 4
|
13.6%
6/44 • Number of events 8
|
|
Gastrointestinal disorders
Salivary gland disorder
|
6.4%
3/47 • Number of events 3
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
3/47 • Number of events 4
|
29.5%
13/44 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
19.1%
9/47 • Number of events 10
|
15.9%
7/44 • Number of events 11
|
|
General disorders
Fatigue
|
55.3%
26/47 • Number of events 35
|
61.4%
27/44 • Number of events 35
|
|
General disorders
Oedema
|
6.4%
3/47 • Number of events 3
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pyrexia
|
6.4%
3/47 • Number of events 3
|
15.9%
7/44 • Number of events 8
|
|
Infections and infestations
Candidiasis
|
6.4%
3/47 • Number of events 3
|
6.8%
3/44 • Number of events 7
|
|
Infections and infestations
Localised infection
|
0.00%
0/47
|
6.8%
3/44 • Number of events 6
|
|
Infections and infestations
Oral infection
|
6.4%
3/47 • Number of events 3
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Paronychia
|
0.00%
0/47
|
18.2%
8/44 • Number of events 10
|
|
Injury, poisoning and procedural complications
Contusion
|
6.4%
3/47 • Number of events 4
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Weight decreased
|
25.5%
12/47 • Number of events 13
|
29.5%
13/44 • Number of events 18
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.0%
8/47 • Number of events 8
|
18.2%
8/44 • Number of events 11
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/47 • Number of events 1
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.5%
12/47 • Number of events 16
|
29.5%
13/44 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.3%
2/47 • Number of events 2
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.5%
4/47 • Number of events 5
|
22.7%
10/44 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/47
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
3/47 • Number of events 5
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.5%
4/47 • Number of events 5
|
2.3%
1/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
3/47 • Number of events 4
|
6.8%
3/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.5%
4/47 • Number of events 4
|
9.1%
4/44 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/47 • Number of events 1
|
11.4%
5/44 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.3%
2/47 • Number of events 3
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
6.4%
3/47 • Number of events 3
|
13.6%
6/44 • Number of events 8
|
|
Nervous system disorders
Dysarthria
|
2.1%
1/47 • Number of events 1
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/47 • Number of events 1
|
9.1%
4/44 • Number of events 4
|
|
Nervous system disorders
Headache
|
17.0%
8/47 • Number of events 9
|
25.0%
11/44 • Number of events 11
|
|
Psychiatric disorders
Depression
|
6.4%
3/47 • Number of events 3
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
4/47 • Number of events 5
|
9.1%
4/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.8%
6/47 • Number of events 6
|
13.6%
6/44 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.5%
4/47 • Number of events 4
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.4%
3/47 • Number of events 3
|
63.6%
28/44 • Number of events 46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.1%
1/47 • Number of events 1
|
11.4%
5/44 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.1%
1/47 • Number of events 1
|
6.8%
3/44 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.3%
2/47 • Number of events 2
|
15.9%
7/44 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
4/47 • Number of events 4
|
15.9%
7/44 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/47
|
6.8%
3/44 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.1%
1/47 • Number of events 1
|
11.4%
5/44 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/47
|
6.8%
3/44 • Number of events 5
|
|
Vascular disorders
Haemorrhage
|
6.4%
3/47 • Number of events 5
|
4.5%
2/44 • Number of events 2
|
|
Vascular disorders
Hypotension
|
4.3%
2/47 • Number of events 2
|
15.9%
7/44 • Number of events 10
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER