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The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zalutumumab 0.15 mg/kg | Experimental |
| |
| Zalutumumab 0.5 mg/kg | Experimental |
| |
| Zalutumumab 1 mg/kg | Experimental |
| |
| Zalutumumab 2 mg/kg | Experimental |
| |
| Zalutumumab 4 mg/kg | Experimental |
| |
| Zalutumumab 8 mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalutumumab | Drug | Weekly infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants reporting at least one adverse event. | From study start (Day 0) until follow-up period (up to Day 77) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR), Classification | Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ã…rhus Kommunehospital | Ã…rhus C | 8000 | Denmark | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17602769 | Result | Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. doi: 10.1016/j.radonc.2007.06.007. Epub 2007 Jun 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zalutumumab 0.15 mg/kg | |
| FG001 | Zalutumumab 0.5 mg/kg | |
| FG002 | Zalutumumab 1 mg/kg | |
| FG003 | Zalutumumab 2 mg/kg | |
| FG004 | Zalutumumab 4 mg/kg | |
| FG005 | Zalutumumab 8 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zalutumumab 0.15 mg/kg | |
| BG001 | Zalutumumab 0.5 mg/kg | |
| BG002 | Zalutumumab 1 mg/kg |
| 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 reporting at least one adverse event. | Number of participants reporting at least one adverse event | Posted | Number | participants | From study start (Day 0) until follow-up period (up to Day 77) |
|
From study start (Day 0) until end of follow-up period (up to Day 77)
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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 0.15 mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
The study comprised a single-dose escalation part for assessment of safety and a repeat dose extension including 4 weekly infusions. Please see the referred publication by Bastholt at al 2007 for detailed results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations Eva Järlid Westerberg | Genmab A/S | +45 7020 2728 | E.Westerberg@genmab.com |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| C546618 | zalutumumab |
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|
| 8 weeks |
| Copenhagen Ø |
| 2100 |
| Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Universitets Sjukhuset i Lund | Lund | 221 85 | Sweden |
| Uppsala Akademiska Sjukhus | Uppsala | 751 85 | Sweden |
| BG003 | Zalutumumab 2 mg/kg |
| BG004 | Zalutumumab 4 mg/kg |
| BG005 | Zalutumumab 8 mg/kg |
| BG006 | 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 |
|
| OG004 | Zalutumumab 4 mg/kg |
| OG005 | Zalutumumab 8 mg/kg |
|
|
| Secondary | Overall Response (OR), Classification | Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is 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. | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Zalutumumab 0.5 mg/kg | 3 | 4 | 4 | 4 |
| EG002 | Zalutumumab 1 mg/kg | 5 | 5 | 5 | 5 |
| EG003 | Zalutumumab 2 mg/kg | 1 | 4 | 4 | 4 |
| EG004 | Zalutumumab 4 mg/kg | 0 | 4 | 4 | 4 |
| EG005 | Zalutumumab 8 mg/kg | 6 | 7 | 7 | 7 |
| Bleeding from tumour | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Administration site condition | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Syncope vasovagal | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Headache | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Rigors | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Sweating increased | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Flushing | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Influenza like | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
|
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| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Partial Response |
|
| Stable Disease |
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| Progression |
|
| Missing |
|