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Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zalutumumab 4-16 mg/kg | Experimental | Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalutumumab | Drug | Individual dose titration weekly i.v. doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as time from start of treatment until date of death of any cause. | From randomization until death, assessed up to 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumour Response | Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steen Lisby, MD | Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0012 | United States | ||
| Loma Linda University Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24714973 | Derived | Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9. |
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All participants attending Visit 2 were included in the FAS irrespective of their compliance with the planned course of zalutumumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zalutumumab 4-16 mg/kg | Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| During treatment and two weeks after end of treatment, assessed up to 21 months. |
| Duration of Response | DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier. | During treatment and two weeks after end of treatment, assessed up to 21 months |
| Progression Free Survival (PFS) | PFS is defined as the time from start of treatment until disease progression or death. | During treatment and two weeks after end of treatment, assessed up to 21 months |
| Loma Linda |
| California |
| 92354 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Ft. Wayne Medical Oncology/Hematology, Inc | Fort Wayne | Indiana | 46815 | United States |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Universitätsklinik für Innere Medizin III | Salzburg | 5020 | Austria |
| AKH Wien | Vienna | 1090 | Austria |
| Instituto Clinico Oncologico del Sur ICOS | Temuco | Chile |
| Hospital Carlos Van Buren de Valparaiso | ValparaÃso | Chile |
| Instituto Oncologico | Viña del Mar | Chile |
| Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A | Bogotá | Colombia |
| Hospital Pablo Tobon Uribe | MedellÃn | Colombia |
| Oncomedica S.A. | MonterÃa | Colombia |
| Oncólogos del Occidente S.A. | Pereira | Colombia |
| Facultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Nemocnice Jihlava | Jihlava | 586 33 | Czechia |
| Veseobecna Fakultni Nemocnice | Prague | 128 08 | Czechia |
| Facultni Nemocnice Na Bulovce | Prague | 180 81 | Czechia |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Klinikum der Johann Wolfgang Goethe Universität | Frankfurt am Main | 60590 | Germany |
| Uniklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Medizinische Universitätsklinik Lübeck | Lübeck | 23538 | Germany |
| Südharz-Krankenhaus Nordhausen gGmbH | Nordhausen | 99734 | Germany |
| Soroka Medical Center | Beersheba | 84101 | Israel |
| Rambam Medial Center | Haifa | 31096 | Israel |
| Shaare-Zedek Medical Center | Jerusalem | 91031 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Istituto Europea di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliera Valtellina e Valchiavenna | Sondrio | 23100 | Italy |
| Hospital Goyeneche | Arequipa | Peru |
| Hospital Nacional Carlos Alberto Seguin Escobedo | Arequipa | Peru |
| Hospital Nacional Almanzor Aguinaga Asenjo | Lambayeque | Peru |
| Hospital Central FAP | Lima | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen | Lima | Peru |
| IPO Coimbra | Coimbra | 3000-075 | Portugal |
| IPO Lisboa | Lisbon | 1099-023 | Portugal |
| IPO Porto | Porto | 4200-072 | Portugal |
| Narodny onkologicky ustav | Bratislava | 83310 | Slovakia |
| FN Trnava | Trnava | 917 75 | Slovakia |
| COMPLETED |
|
| NOT COMPLETED |
|
All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zalutumumab 4-16 mg/kg | Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Overall Survival (OS) | OS was defined as time from start of treatment until date of death of any cause. | All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. | Posted | Median | 95% Confidence Interval | months | From randomization until death, assessed up to 21 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Objective Tumour Response | Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the 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. | All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are number of participants with data available for analysis of best response. | Posted | Number | participants | During treatment and two weeks after end of treatment, assessed up to 21 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Response | DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier. | All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are the number of participants with a response. | Posted | Median | 95% Confidence Interval | days | During treatment and two weeks after end of treatment, assessed up to 21 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from start of treatment until disease progression or death. | All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. | Posted | Median | 95% Confidence Interval | months | During treatment and two weeks after end of treatment, assessed up to 21 months |
|
|
From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
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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 | Zalutumumab 4-16 mg/kg | Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. | 83 | 90 | 90 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| OESOPHAGEAL FISTULA | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| CATHETER RELATED INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| EYE INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (6.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| QUADRIPARESIS | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RENAL TUBULAR DISORDER | Renal and urinary disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYDROPNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RESPIRATORY ACIDOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA (6.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (6.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RHONCHI | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
|
This was an uncontrolled single-arm open-label trial with no formal statistical tests planned.
The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor.
The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Järlid Westerberg, VP Clinical Operations | Genmab A/S | +45 7020 2728 | E.Westerberg@genmab.com |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C546618 | zalutumumab |
Not provided
Not provided
Not provided
| Czech Republic |
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| Slovakia |
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| Peru |
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| Austria |
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| Israel |
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| Chile |
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| Germany |
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| Colombia |
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| Italy |
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