Zalutumumab in Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00093041
First received: September 30, 2004
Last updated: November 17, 2011
Last verified: November 2011
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Neoplasms
Intervention: Drug: Zalutumumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zalutumumab 0.15 mg/kg No text entered.
Zalutumumab 0.5 mg/kg No text entered.
Zalutumumab 1 mg/kg No text entered.
Zalutumumab 2 mg/kg No text entered.
Zalutumumab 4 mg/kg No text entered.
Zalutumumab 8 mg/kg No text entered.

Participant Flow:   Overall Study
    Zalutumumab 0.15 mg/kg     Zalutumumab 0.5 mg/kg     Zalutumumab 1 mg/kg     Zalutumumab 2 mg/kg     Zalutumumab 4 mg/kg     Zalutumumab 8 mg/kg  
STARTED     4     4     5     4     4     7  
COMPLETED     2 [1]   1 [2]   3 [3]   3 [4]   3 [5]   4 [6]
NOT COMPLETED     2     3     2     1     1     3  
[1] One discontinued during single dose period and one during multiple dose period
[2] Three discontinued during single dose period
[3] Two discontinued during single dose period
[4] One discontinued during single dose period
[5] One discontinued during multiple dose period
[6] Three discontinued during multiple dose period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zalutumumab 0.15 mg/kg No text entered.
Zalutumumab 0.5 mg/kg No text entered.
Zalutumumab 1 mg/kg No text entered.
Zalutumumab 2 mg/kg No text entered.
Zalutumumab 4 mg/kg No text entered.
Zalutumumab 8 mg/kg No text entered.
Total Total of all reporting groups

Baseline Measures
    Zalutumumab 0.15 mg/kg     Zalutumumab 0.5 mg/kg     Zalutumumab 1 mg/kg     Zalutumumab 2 mg/kg     Zalutumumab 4 mg/kg     Zalutumumab 8 mg/kg     Total  
Number of Participants  
[units: participants]
  4     4     5     4     4     7     28  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     4     4     4     3     4     6     25  
>=65 years     0     0     1     1     0     1     3  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 49 to 62 )  
  59  
  ( 49 to 63 )  
  57  
  ( 56 to 68 )  
  55  
  ( 50 to 76 )  
  53  
  ( 47 to 61 )  
  58  
  ( 52 to 67 )  
  57  
  ( 47 to 79 )  
Gender  
[units: participants]
             
Female     2     1     1     1     0     1     6  
Male     2     3     4     3     4     6     22  
Region of Enrollment  
[units: participants]
             
Denmark     4     3     3     3     4     6     23  
Sweden     0     1     2     1     0     1     5  



  Outcome Measures
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1.  Primary:   Adverse Events   [ Time Frame: Overall Study ]

2.  Secondary:   Overall Response, Classification   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: VP Clinical Operations Eva Järlid Westerberg
Organization: Genmab A/S
phone: +45 7020 2728
e-mail: E.Westerberg@genmab.com


Publications of Results:

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00093041     History of Changes
Other Study ID Numbers: Zalutumumab
Study First Received: September 30, 2004
Results First Received: September 12, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration