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Zalutumumab in Patients With Non-curable Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00382031
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : October 15, 2013
Last Update Posted : October 15, 2013
Sponsor:
Information provided by (Responsible Party):
Genmab

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Cancer
Squamous Cell Cancer
Interventions Drug: Zalutumumab
Other: Control
Enrollment 286
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed. Best Supportive Care
Period Title: Overall Study
Started 191 [1] 95 [2]
Completed 191 95
Not Completed 0 0
[1]
Of the 191 randomized patients 189 received at least one infusion of zalutumumab
[2]
Of the 95 randomized patients 94 attended Visit2.
Arm/Group Title Zalutumumab Control Total
Hide Arm/Group Description Zalutumumab in combination with Best Supportive Care Best Supportive Care Total of all reporting groups
Overall Number of Baseline Participants 191 95 286
Hide Baseline Analysis Population Description
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 95 participants 286 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
161
  84.3%
77
  81.1%
238
  83.2%
>=65 years
30
  15.7%
18
  18.9%
48
  16.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 95 participants 286 participants
57  (9) 57  (9) 57  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 95 participants 286 participants
Female
22
  11.5%
12
  12.6%
34
  11.9%
Male
169
  88.5%
83
  87.4%
252
  88.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 191 participants 95 participants 286 participants
Serbia 5 1 6
Estonia 3 1 4
Spain 1 4 5
Lithuania 2 0 2
Russian Federation 42 22 64
United Kingdom 22 10 32
France 13 3 16
Hungary 37 20 57
Canada 10 8 18
Brazil 7 4 11
Belgium 31 20 51
Poland 14 2 16
Sweden 4 0 4
1.Primary Outcome
Title Overall Survival
Hide Description A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.
Time Frame From randomization until death
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description:
Zalutumumab in combination with Best Supportive Care
Best Supportive Care
Overall Number of Participants Analyzed 191 95
Median (95% Confidence Interval)
Unit of Measure: months
6.7
(5.8 to 7.1)
5.2
(4.1 to 6.4)
2.Secondary Outcome
Title Objective Tumor Response
Hide Description Objective tumor response assessed 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 From date of randomization until the date of death from any cause, assessed up to 41 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description:
Zalutumumab in combination with Best Supportive Care
Best Supportive Care
Overall Number of Participants Analyzed 191 95
Measure Type: Number
Unit of Measure: participants
Complete response 2 0
Partial response 10 1
Stable disease 79 25
Progressive disease 70 38
Not evaluable 30 31
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.
Time Frame Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description:
Zalutumumab in combination with Best Supportive Care
Best Supportive Care
Overall Number of Participants Analyzed 12 1
Median (95% Confidence Interval)
Unit of Measure: month
5.5
(3.6 to 23.0)
7.4 [1] 
(NA to N/A)
[1]
CI not available as it was only one patient
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.
Time Frame From randomization until disease progression or death, assessed up to 41 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description:
Zalutumumab in combination with Best Supportive Care
Best Supportive Care
Overall Number of Participants Analyzed 191 95
Median (95% Confidence Interval)
Unit of Measure: weeks
9.9
(8.7 to 15.0)
8.4
(8.1 to 9.6)
Time Frame Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group.
Adverse Event Reporting Description The safety analysis population included all 283 patients who had attended Visit 2.
 
Arm/Group Title Zalutumumab Control
Hide Arm/Group Description Zalutumumab in combination with Best Supportive Care Best Supportive Care
All-Cause Mortality
Zalutumumab Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Zalutumumab Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   180/189 (95.24%)      87/94 (92.55%)    
Gastrointestinal disorders     
Gastrointestinal disorders  1  19/189 (10.05%)  20 3/94 (3.19%)  3
Dysphagia  1  10/189 (5.29%)  10 2/94 (2.13%)  2
General disorders     
General disorders and administration site conditions  1  127/189 (67.20%)  138 63/94 (67.02%)  64
Disease progression  1  118/189 (62.43%)  118 60/94 (63.83%)  60
Infections and infestations     
Infections and Infestations  1  35/189 (18.52%)  46 11/94 (11.70%)  11
Pneumonia  1  14/189 (7.41%)  15 3/94 (3.19%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1  38/189 (20.11%)  48 22/94 (23.40%)  27
Tumour hemorrhage  1  32/189 (16.93%)  41 14/94 (14.89%)  17
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 Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   188/189 (99.47%)      92/94 (97.87%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  66/189 (34.92%)  121 26/94 (27.66%)  44
Eye disorders     
Eye disorders  1  24/189 (12.70%)  37 5/94 (5.32%)  5
Gastrointestinal disorders     
Gastrointestinal disorders  1  102/189 (53.97%)  298 43/94 (45.74%)  119
General disorders     
General disorders and administration site conditions  1  159/189 (84.13%)  359 78/94 (82.98%)  161
Infections and infestations     
Infections and Infestations  1  79/189 (41.80%)  171 29/94 (30.85%)  35
Investigations     
Investigations  1  56/189 (29.63%)  77 12/94 (12.77%)  14
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  77/189 (40.74%)  150 20/94 (21.28%)  27
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  46/189 (24.34%)  78 27/94 (28.72%)  41
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1  50/189 (26.46%)  75 30/94 (31.91%)  39
Nervous system disorders     
Nervous system disorders  1  70/189 (37.04%)  114 22/94 (23.40%)  38
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  1  80/189 (42.33%)  177 33/94 (35.11%)  51
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  174/189 (92.06%)  355 10/94 (10.64%)  13
Vascular disorders     
Vascular disorders  1  28/189 (14.81%)  38 7/94 (7.45%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
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: NCT00382031    
Other Study ID Numbers: Hx-EGFr-202
First Submitted: September 27, 2006
First Posted: September 28, 2006
Results First Submitted: May 28, 2013
Results First Posted: October 15, 2013
Last Update Posted: October 15, 2013