TRC105 for Liver Cancer That Has Not Responded to Sorafenib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tim Greten, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01375569
First received: June 16, 2011
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: March 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatocellular Carcinoma
Hepatocellular Cancer
Carcinoma, Hepatocellular
Intervention: Drug: TRC105

  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
TRC105 in Liver Cancer TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.

Participant Flow:   Overall Study
    TRC105 in Liver Cancer  
STARTED     11  
COMPLETED     11  
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
TRC105 in Liver Cancer TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.

Baseline Measures
    TRC105 in Liver Cancer  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     1  
Age  
[units: years]
Mean (Standard Deviation)
  54.46  (12.8)  
Gender  
[units: participants]
 
Female     2  
Male     9  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     11  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     5  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).   [ Time Frame: 2 years ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 25 months, 15 days ]


  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 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.


Results Point of Contact:  
Name/Title: Dr. Tim Greten
Organization: National Cancer Institute
phone: 301-451-4723
e-mail: gretentf@mail.nih.gov


Publications:

Responsible Party: Tim Greten, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01375569     History of Changes
Other Study ID Numbers: 110181
11-C-0181
Study First Received: June 16, 2011
Results First Received: March 4, 2015
Last Updated: February 18, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration