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MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years.
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The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zalutumumab 4 mg/kg | Experimental | Zalutumumab 8 weekly infusions |
|
| Zalutumumab 8 mg/kg | Experimental | Zalutumumab 8 weekly infusions |
|
| Zalutumumab 12 mg/kg | Experimental | Zalutumumab 8 weekly infusions |
|
| Zalutumumab 16 mg/kg | Experimental | Zalutumumab 8 weekly infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zalutumumab | Drug | Eight weekly infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial. | Overall Study |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | Up to 3 years |
| Time to Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Gregoire, MD professor | St-Luc University Hospital, Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences Center | Portland | Oregon | 97239 | United States | ||
| St-Luc University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zalutumumab 4 mg/kg | Zalutumumab 8 weekly infusions |
| FG001 | Zalutumumab 8 mg/kg | Zalutumumab 8 weeky infusions |
| FG002 | Zalutumumab 12 mg/kg | Zalutumumab 8 weekly infusions |
| FG003 | Zalutumumab 16 mg/kg | Zalutumumab 8 weekly infusions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zalutumumab 4 mg/kg | Zalutumumab 8 weekly infusions |
| BG001 | Zalutumumab 8 mg/kg | Zalutumumab 8 weeky infusions |
| 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 |
| 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 | Adverse Events | Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial. | Posted | Number | participants | Overall Study |
|
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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 mg/kg | Zalutumumab 8 weekly infusions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
All adverse events were collected during the 8 week treatment period and for additional 4 weeks. Serious adverse events were collected for the extended follow-up period of up to 3 years.
The planned parallell group of the study was cancelled.
| 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 |
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| ID | Term |
|---|---|
| C546618 | zalutumumab |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin | Drug | Infusions |
|
| Radiotherapy | Procedure | Daily in the treatment period |
|
Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 |
| Up to 3 years |
| Best Overall Tumor Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | Up to 3 years |
| Brussels |
| Belgium |
| University Hospital Gasthuisberg | Leuven | Belgium |
| Centre Georges-Francois Leclerc Hospital | Dijon | France |
| Hopital Bretonneau Clinique d'Oncologie et Radiothérapie | Tours | France |
| Nijmegen University Hospital | Nijmegen | Netherlands |
| Lund University Hospital | Lund | Sweden |
| BG002 |
| Zalutumumab 12 mg/kg |
Zalutumumab 8 weekly infusions |
| BG003 | Zalutumumab 16 mg/kg | Zalutumumab 8 weekly infusions |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | Posted | Number | Participants | Up to 3 years |
|
|
|
| Secondary | Time to Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | Number of months between date of first infusion and date of best response | Posted | Median | Full Range | months | Up to 3 years |
|
|
|
| Secondary | Best Overall Tumor Response | Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | Posted | Number | Participants | Up to 3 years |
|
|
|
| 5 |
| 6 |
| 6 |
| 6 |
| EG001 | Zalutumumab 8 mg/kg | Zalutumumab 8 weeky infusions | 6 | 6 | 6 | 6 |
| EG002 | Zalutumumab 12 mg/kg | Zalutumumab 8 weekly infusions | 5 | 6 | 6 | 6 |
| EG003 | Zalutumumab 16 mg/kg | Zalutumumab 8 weekly infusions | 11 | 12 | 12 | 12 |
| Cardiac failure | Cardiac disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Sigmoiditis | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Death | General disorders |
|
| Disease progression | General disorders |
|
| General physical health deterioration | General disorders |
|
| Infusion related reaction | General disorders |
|
| Mucosal inflammation | General disorders |
|
| Pyrexia | General disorders |
|
| Bronchopneumonia | Infections and infestations |
|
| Herpes dermatitis | Infections and infestations |
|
| Infection in immunocompromised host | Infections and infestations |
|
| Meningitis | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Post procedural infection | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Femur fracture | Injury, poisoning and procedural complications |
|
| Radiation skin injury | Injury, poisoning and procedural complications |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Fistula | Musculoskeletal and connective tissue disorders |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Lung squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Nasopharyngeal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Oropharyngeal cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Oropharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Cerebral ischaemia | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Renal failure acute | Renal and urinary disorders |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
| Iliac artery occlusion | Vascular disorders |
|
| Febrile neutropenia | Blood and lymphatic system disorders |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Hearing impaired | Ear and labyrinth disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Chills | General disorders |
|
| Disease progression | General disorders |
|
| Fatigue | General disorders |
|
| Mucosal inflammation | General disorders |
|
| Pyrexia | General disorders |
|
| Laryngitis | Infections and infestations |
|
| Pharyngitis | Infections and infestations |
|
| Radiation skin injury | Injury, poisoning and procedural complications |
|
| Weight decreased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypomagnesaemia | Metabolism and nutrition disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
| Dermatitis | Skin and subcutaneous tissue disorders |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
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.
| D013812 |
| Therapeutics |
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|
| Nonevaluable |
|