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Trial record 1 of 1 for:    An Open label single arm trial investigating zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination
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Zalutumumab in Non-curable Patients With SCCHN

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ClinicalTrials.gov Identifier: NCT00542308
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Genmab

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Head and Neck Cancer
Squamous Cell Cancer
Intervention Drug: Zalutumumab
Enrollment 90
Recruitment Details  
Pre-assignment Details All patients attending Visit 2 were included in the FAS irrespective of their compliance with the planned course of zalutumumab.
Arm/Group Title Zalutumumab 4-16 mg/kg
Hide Arm/Group Description Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Period Title: Overall Study
Started 90
Completed 90
Not Completed 0
Arm/Group Title Zalutumumab 4-16 mg/kg
Hide Arm/Group Description Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
<=18 years
0
   0.0%
Between 18 and 65 years
70
  77.8%
>=65 years
20
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
59.1  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
18
  20.0%
Male
72
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants
Portugal 10
United States 22
Czech Republic 6
Slovakia 4
Peru 4
Austria 3
Israel 12
Chile 8
Germany 11
Colombia 1
Italy 9
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was defined as time from start of treatment until date of death of any cause.
Time Frame From randomization until death, assessed up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
Arm/Group Title Zalutumumab 4-16 mg/kg
Hide Arm/Group Description:
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Overall Number of Participants Analyzed 90
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(4.1 to 7.1)
2.Secondary Outcome
Title Tumour Response
Hide Description Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)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
Time Frame During treatment and two weeks after end of treatment, assessed up to 21 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
Arm/Group Title Zalutumumab 4-16 mg/kg
Hide Arm/Group Description:
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Complete response 1
Partial response 4
Stable response 30
Progressive disease 33
Not evaluable 20
Time Frame Adverse events were collected at weekly visits until disease progression, intercurrent illness preventing further administration, unacceptable toxicity, or patient decision.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zalutumumab 4-16 mg/kg
Hide Arm/Group Description Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
All-Cause Mortality
Zalutumumab 4-16 mg/kg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Zalutumumab 4-16 mg/kg
Affected / at Risk (%) # Events
Total   83/90 (92.22%)    
Gastrointestinal disorders   
Gastrointestinal disorders  1  8/90 (8.89%)  9
Dysphagia  1  5/90 (5.56%)  6
General disorders   
General disorders and administration site conditions  1  61/90 (67.78%)  64
Disease progression  1  55/90 (61.11%)  55
Infections and infestations   
Infections and infestations  1  16/90 (17.78%)  19
Pneumonia  1  7/90 (7.78%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified  1  9/90 (10.00%)  9
Tumor hemorrhage  1  6/90 (6.67%)  6
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders  1  17/90 (18.89%)  22
Dyspnea  1  9/90 (10.00%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zalutumumab 4-16 mg/kg
Affected / at Risk (%) # Events
Total   90/90 (100.00%)    
Blood and lymphatic system disorders   
Blood and lymphatic system disorders  1  13/90 (14.44%)  16
Eye disorders   
Eye disorders  1  10/90 (11.11%)  12
Gastrointestinal disorders   
Gastrointestinal disorders  1  49/90 (54.44%)  131
General disorders   
General disorders and administration site conditions  1  77/90 (85.56%)  210
Infections and infestations   
Infections and infestations  1  49/90 (54.44%)  100
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications  1  13/90 (14.44%)  19
Investigations   
Investigations  1  22/90 (24.44%)  46
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1  40/90 (44.44%)  72
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders  1  29/90 (32.22%)  40
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified  1  21/90 (23.33%)  28
Nervous system disorders   
Nervous system disorders  1  28/90 (31.11%)  46
Psychiatric disorders   
Psychiatric disorders  1  19/90 (21.11%)  22
Renal and urinary disorders   
Renal and urinary disorders  1  11/90 (12.22%)  13
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders  1  42/90 (46.67%)  75
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders  1  72/90 (80.00%)  138
Vascular disorders   
Vascular disorders  1  14/90 (15.56%)  17
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
This was an uncontrolled single-arm open-label trial with no formal statistical tests planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eva Järlid Westerberg, VP Clinical Operations
Organization: Genmab A/S
Phone: +45 7020 2728
EMail: E.Westerberg@genmab.com
Layout table for additonal information
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00542308    
Other Study ID Numbers: GEN205
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: August 12, 2014
Results First Posted: August 27, 2014
Last Update Posted: August 27, 2014