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| ID | Type | Description | Link |
|---|---|---|---|
| CP13-0706 | Other Identifier | ImClone, LLC | |
| CP02-0758 | Other Identifier | ImClone, LLC | |
| I5A-IE-JAEB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved but still leave a percentage of participants with incurable disease. New alternatives for participants whose disease is refractory to existing therapies is needed.
IMC-A12 is a monoclonal antibody which binds to special receptors known as insulin-like growth factor-I receptor (IGF-IR). This binding action has been shown to inhibit the growth of a variety of human tumor cell lines.
The purpose of this study is to evaluate the effects of IMC-A12 by itself or with Cetuximab (Erbitux®) in participants with Squamous Cell Carcinoma Head and Neck Cancer that has spread to other parts of the body, and to determine how long the drug remains in the body. The study will also look at what side effects IMC-A12 may cause when a participant is receiving treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-A12 (cixutumumab) | Experimental |
| |
| IMC-A12 (cixutumumab) + cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 (cixutumumab) | Biological | IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Baseline to measured PD (up to 27.66 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Orange | California | 92868 | United States | ||
| ImClone Investigational Site |
Presented are the reasons the participants discontinued from the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| cetuximab (Erbitux ®) | Biological | IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops. |
|
|
| Baseline to measured PD (up to 27.66 months) |
| Percentage of Participants With PFS at 6 Months | 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. | 6 months |
| Overall Survival (OS) | 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. | Baseline to date of death from any cause (up to 29.63 months) |
| 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. | Date of first response to the date of PD or death due to any cause (up to 23.98 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | 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. | Baseline through study completion (up to 29.63 months) |
| Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab | No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay. | 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] |
| Miami |
| Florida |
| 33136 |
| United States |
| ImClone Investigational Site | Orlando | Florida | 32806 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30322 | United States |
| ImClone Investigational Site | Chicago | Illinois | 60637 | United States |
| ImClone Investigational Site | Baltimore | Maryland | 21231 | United States |
| ImClone Investigational Site | Boston | Massachusetts | 02115 | United States |
| ImClone Investigational Site | Rochester | Minnesota | 55905 | United States |
| ImClone Investigational Site | New York | New York | 10003 | United States |
| ImClone Investigational Site | The Bronx | New York | 10467 | United States |
| ImClone Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| ImClone Investigational Site | Nashville | Tennessee | 37232 | United States |
| ImClone Investigational Site | Houston | Texas | 77030 | United States |
| ImClone Investigational Site | Charlottesville | Virginia | 22908 | United States |
| FG001 |
| 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. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMC-A12 (Cixutumumab) | 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. |
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
| |||||||||||||||
| Body Surface Area (BSA) | 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. | Mean | Standard Deviation | square meters (m^2) |
| ||||||||||||||
| Electrocardiogram (ECG) | Count of Participants | Participants | No |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | 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. | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Baseline to measured PD (up to 27.66 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 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. | Randomized participants who received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to measured PD (up to 27.66 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PFS at 6 Months | 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. | Randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Baseline to date of death from any cause (up to 29.63 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response. | Posted | Median | 95% Confidence Interval | months | Date of first response to the date of PD or death due to any cause (up to 23.98 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | 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. | Randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline through study completion (up to 29.63 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab | No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay. | No participants were analyzed due to lack of an appropriate validated assay. | Posted | 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] |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMC-A12 (Cixutumumab) | 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. | 20 | 47 | 44 | 47 | ||
| EG001 | 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 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. | 23 | 44 | 44 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Scotoma | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrostomy tube insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C557414 | cixutumumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Abnormal |
|
| 1 = Ambulatory, Restricted Work Activity |
|
| 2 = Ambulatory, No Work Activity |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
| Participants |
|