Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01623869
First received: June 17, 2012
Last updated: June 5, 2015
Last verified: December 2014
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Angiosarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Biological: Trebananib
Other: Laboratory Biomarker Analysis

  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
Treatment (Trebananib) Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Trebananib)  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     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.
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Reporting Groups
  Description
Treatment (Trebananib) Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Trebananib)  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Median (Full Range)
  68.5   (24 to 91)  
Gender  
[units: participants]
 
Female     10  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Confirmed Response Rate (CR or PR) Using RECIST   [ Time Frame: Up to 18 months ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months ]

3.  Secondary:   OS   [ Time Frame: From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sandra Pierina D'Angelo, M.D.
Organization: Memorial Sloan-Kettering Cancer Center
e-mail: dangelos@mskcc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01623869     History of Changes
Other Study ID Numbers: NCI-2012-01978, NCI-2012-01978, CDR0000735380, CALGB-A091103, A091103, A091103, U10CA180821, U10CA031946
Study First Received: June 17, 2012
Results First Received: June 5, 2015
Last Updated: June 5, 2015
Health Authority: United States: Food and Drug Administration