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Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by (Responsible Party):
Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:
NCT00377429
First received: September 15, 2006
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
Results First Received: March 15, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: catumaxomab

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Catumaxomab 4 dose series (10-20-50-150 micrograms) within 21 days

Participant Flow:   Overall Study
    Catumaxomab  
STARTED     47 [1]
COMPLETED     32 [2]
NOT COMPLETED     15  
Withdrawal by Subject                 5  
Adverse Event                 8  
Physician Decision                 1  
Patient non-compliance                 1  
[1] Treated
[2] Completed main study



  Baseline Characteristics
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Reporting Groups
  Description
Catumaxomab 4 dose series (10-20-50-150 micrograms) within 21 days

Baseline Measures
    Catumaxomab  
Number of Participants  
[units: participants]
 		  47  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation 		  56.6  ± 9.36  
Gender  
[units: participants]
 		 
Female     47  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     47  



  Outcome Measures
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1.  Primary:   Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days   [ Time Frame: 21 days ]
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2.  Secondary:   Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy   [ Time Frame: 2 months ]
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3.  Secondary:   Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)   [ Time Frame: Baseline ]
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4.  Secondary:   Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)   [ Time Frame: 2 years ]
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5.  Secondary:   Number of Participants Who Survived (Post-study at 24 Month Visit)   [ Time Frame: 2 years ]
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6.  Secondary:   Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)   [ Time Frame: 3 months ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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
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Results Point of Contact:  
Name/Title: Anne Kuan
Organization: Fresenius Biotech
phone: 781 699 4618
e-mail: anne.kuan@fresenius-biotech.com


Publications:


Responsible Party: Fresenius Biotech GmbH
ClinicalTrials.gov Identifier: NCT00377429     History of Changes
Other Study ID Numbers: IP-CAT-OC-01
Study First Received: September 15, 2006
Results First Received: March 15, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration