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TRC105 for Recurrent Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01778530
Recruitment Status : Terminated (Study was terminated due to poor accrual.)
First Posted : January 29, 2013
Results First Posted : May 12, 2014
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Joohee Sul, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Intervention Drug: TRC105
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TRC105 for Recurrent Glioblastoma
Hide Arm/Group Description TRC105: Intravenous infusion.
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Progression on study             1
Adverse event/side effect             1
Arm/Group Title TRC105 for Recurrent Glioblastoma
Hide Arm/Group Description TRC105: Intravenous infusion.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
48  (7.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.
Hide Description Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,
Time Frame 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not met due to termination of the study for poor accrual.
Arm/Group Title TRC105 for Recurrent Glioblastoma
Hide Arm/Group Description:
TRC105: Intravenous infusion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For details, see the adverse event module.
Time Frame 5 months, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 for Recurrent Glioblastoma
Hide Arm/Group Description:
TRC105: Intravenous infusion.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TRC105 for Recurrent Glioblastoma
Hide Arm/Group Description TRC105: Intravenous infusion.
All-Cause Mortality
TRC105 for Recurrent Glioblastoma
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TRC105 for Recurrent Glioblastoma
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
General disorders   
Infusion related reaction  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TRC105 for Recurrent Glioblastoma
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
General disorders   
Fatigue  1  1/2 (50.00%)  1
Investigations   
Lymphocyte count decreased  1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/2 (50.00%)  1
Hypophosphatemia  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/2 (50.00%)  1
Nervous system disorders   
Headache  1  1/2 (50.00%)  1
Seizure  1  1/2 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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. Joohee Sul
Organization: National Cancer Institute
Phone: 301-402-6298
Responsible Party: Joohee Sul, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01778530     History of Changes
Obsolete Identifiers: NCT01757652
Other Study ID Numbers: 130048
13-C-0048
First Submitted: January 26, 2013
First Posted: January 29, 2013
Results First Submitted: April 10, 2014
Results First Posted: May 12, 2014
Last Update Posted: October 7, 2015