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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000902-24 | EudraCT Number |
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The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.
Symphogen was the sponsor for planning/conducting and reporting results for this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sym004 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sym004 | Drug | Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Time | The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates. | Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate) | Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1. CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial. |
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Inclusion Criteria:
Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Horak, MD, FACP | Symphogen A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3203; Antwerp University Hospital; Department of Medical Oncology | Antwerp | Edegem | 2650 | Belgium | ||
| 3202; Jules Bordet Institute; Clinique d'Oncologie Médicale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25952795 | Derived | Machiels JP, Specenier P, Krauss J, Dietz A, Kaminsky MC, Lalami Y, Henke M, Keilholz U, Knecht R, Skartved NJ, Horak ID, Pamperin P, Braun S, Gauler TC. A proof of concept trial of the anti-EGFR antibody mixture Sym004 in patients with squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2015 Jul;76(1):13-20. doi: 10.1007/s00280-015-2761-4. Epub 2015 May 8. |
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A total of 28 subjects were screened for eligibility, 2 were excluded (mainly non-fulfillment of inclusion or exclusion criteria) and 26 subjects were randomized.
First subject (informed consent): 15 July 2011. Last subject completed: 08 October 2012; Clinical data cut-off: 08 October 2012. Subjects randomized at 10 centers in Belgium, France and Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sym004 | Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set (FAS) comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sym004 | Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) Time | The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. | Posted | Median | 95% Confidence Interval | days | Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks |
From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration
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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 | Sym004 | Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Symphogen A/S | +45 8838 2600 | info@symphogen.com |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C569270 | futuximab |
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| Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months |
| Duration of Overall Response | Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available. | Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months |
| Time to Progression (TTP) | The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP. | Time from first infusion of Sym04 until disease progression, assessed up to 18 months |
| Overall Survival Time | Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored. | Time from first infusion of Sym004 until death, assessed up to 18 months |
| Number of Subjects With Detectable Biomarkers at Any Visit | The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells. | Weeks 0 and 4; and 4 weeks after last dose |
| Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168]) | The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve. | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf]) | The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Maximum Serum Concentration (Cmax) | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Minimum Serum Concentration (Cmin) | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Clearance (CL) | Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Terminal Half Life (T1/2) | The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination. | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Time to Reach Maximum Serum Concentration (Tmax) | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Time to Reach Minimum Serum Concentration (Tmin) | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Volume of Distribution (Vz) | Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
| Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration |
| Brussels |
| 1000 |
| Belgium |
| 3201; Cliniques Universitaires St-Luc; Centre du Cancer | Brussels | 1200 | Belgium |
| 3303; Centre Alexis Vautrin; Département d'Oncologie Médicale | Nancy | Vandoeuvre Les Nancy | 54111 | France |
| 4905; Charité Campus Benjamin Franklin; Hematology, Oncology and Transfusion Medicine | Berlin | 12200 | Germany |
| 4901; Universitätsklinikum Essen | Essen | 45122 | Germany |
| 4904; Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| 4906; University Medical Center Hamburg Eppendorf; Department of Otorhinolaryngology and Head and Neck Surgery | Hamburg | 20246 | Germany |
| 4907; University Hospital Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT) | Heidelberg | 6912 | Germany |
| 4902; University of Leipzig | Leipzig | 04103 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Sym004 | Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment. |
|
|
| Secondary | Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate) | Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1. CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months |
|
|
|
| Secondary | Duration of Overall Response | Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available. | Duration of overall response could not be calculated as no subject showed CR or PR. | Posted | Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months |
|
|
| Secondary | Time to Progression (TTP) | The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. | Posted | Median | 95% Confidence Interval | days | Time from first infusion of Sym04 until disease progression, assessed up to 18 months |
|
|
|
| Secondary | Overall Survival Time | Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. | Posted | Median | 95% Confidence Interval | days | Time from first infusion of Sym004 until death, assessed up to 18 months |
|
|
|
| Secondary | Number of Subjects With Detectable Biomarkers at Any Visit | The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. "n" signifies subjects evaluable for specified biomarker type. | Posted | Number | Subjects | Weeks 0 and 4; and 4 weeks after last dose |
|
|
|
| Secondary | Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168]) | The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | microgram-hour/milliliter | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf]) | The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | microgram-hour/milliliter | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | microgram/milliliter | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Minimum Serum Concentration (Cmin) | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | microgram/milliliter | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Clearance (CL) | Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | milliliter/hour/kilogram | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Terminal Half Life (T1/2) | The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | hour | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Time to Reach Maximum Serum Concentration (Tmax) | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | hour | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Time to Reach Minimum Serum Concentration (Tmin) | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | hour | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Volume of Distribution (Vz) | Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. 'n' signifies subjects who were evaluable at given time points. | Posted | Mean | Standard Deviation | milliliter/kilogram | Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3 |
|
|
|
| Secondary | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. | Posted | Number | Subjects | From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration |
|
|
|
| 20 |
| 26 |
| 26 |
| 26 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Jejunal perforation | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tumor haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Prosthesis implantation | Surgical and medical procedures | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Oedema peripheral | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Device leakage | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Device occlusion | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Xerosis | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Aphthous stomatitis' | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dermatitis infected | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Sputum purulent | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Endocrine disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| Title | Measurements |
|---|---|
|
| PD |
|
| Title | Measurements |
|---|---|
|
| Tumor biopsy: HER2 (n=17) |
|
| Tumor biopsy: HER3 (n=17) |
|
| Skin biopsy: EGFR (n=18) |
|
| Tumor biopsy: EGFR (n=11) |
|
| Tumor biopsy: pEGFR (n=26) |
|
| Skin biopsy: pEGFR (n=26) |
|
| Skin biopsy: Increase in Ki67 (n=18) |
|
| Skin biopsy: Decrease in Ki67 (n=18) |
|
| Tumor biopsy: Decrease in Ki67 (n=11) |
|
| Title | Measurements |
|---|---|
|
| AEs Leading to Discontinuation |
|