Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer (GEN206)

This study has been terminated.
(Due to changes in portfolio review)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00677924
First received: May 13, 2008
Last updated: November 21, 2011
Last verified: November 2011
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
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
Zalatumumab 8 mg/kg No text entered.
Zalutumumab 16 mg/kg No text entered.

Participant Flow:   Overall Study
    Zalatumumab 8 mg/kg     Zalutumumab 16 mg/kg  
STARTED     3     6  
COMPLETED     3     6  
NOT COMPLETED     0     0  



  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
Zalatumumab 8 mg/kg No text entered.
Zalutumumab 16 mg/kg No text entered.
Total Total of all reporting groups

Baseline Measures
    Zalatumumab 8 mg/kg     Zalutumumab 16 mg/kg     Total  
Number of Participants  
[units: participants]
  3     6     9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     5     7  
>=65 years     1     1     2  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 57 to 66 )  
  61  
  ( 33 to 76 )  
  61  
  ( 33 to 76 )  
Gender  
[units: participants]
     
Female     1     5     6  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
Belgium     3     6     9  



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

2.  Secondary:   Best Overall Response   [ Time Frame: Overall Study ]


  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 when 9 out of 97 patients were enrolled. The trial design was originally divided in two parts. Patient allocation was terminated before Part 2 was started.  


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


Publications of Results:
Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)


Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00677924     History of Changes
Other Study ID Numbers: GEN206
Study First Received: May 13, 2008
Results First Received: September 12, 2011
Last Updated: November 21, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products