Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

This study has been terminated.
(Due to considerations regarding the appropriate therapeutic regimen for these patients.)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00460551
First received: April 12, 2007
Last updated: December 5, 2011
Last verified: December 2011
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Biological: Zalutumumab
Drug: Induction chemotherapy
Radiation: Radiotherapy

  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 8 mg/kg No text entered.

Participant Flow:   Overall Study
    Zalutumumab 8 mg/kg  
STARTED     13  
COMPLETED     13 [1]
NOT COMPLETED     0  
[1] The trial was terminated after Period 1A. Only safety was measured.



  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 8 mg/kg No text entered.

Baseline Measures
    Zalutumumab 8 mg/kg  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     6  
Age  
[units: years]
Median ( Full Range )
  66  
  ( 42 to 78 )  
Gender  
[units: participants]
 
Female     3  
Male     10  
Region of Enrollment  
[units: participants]
 
France     2  
United States     2  
Belgium     6  
Netherlands     1  
United Kingdom     2  



  Outcome Measures
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1.  Primary:   Progression Free Survival Verified by Imaging Techniques.   [ Time Frame: Until disease progression ]

2.  Secondary:   Adverse Events   [ Time Frame: Up to 3 months ]


  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 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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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 trial was prematurely closed. The original protocol contained Part 1A, followed by Part 1B and Part 2. The trial was terminated when 13 patients were enrolled in Part 1A. Scans for efficacy were planned for Part 1B and Part 2.  


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


No publications provided


Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00460551     History of Changes
Other Study ID Numbers: GEN204
Study First Received: April 12, 2007
Results First Received: September 12, 2011
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency