Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00937495
First received: July 10, 2009
Last updated: April 25, 2014
Last verified: September 2013
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Drug: vorinostat
Drug: bortezomib

  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
Sixteen patients were accrued to this study from June 2009 through July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant received commercial drug instead of study drug and was deemed a violation. Another participant did not have a post baseline measurement scan and by protocol is not evaluable for the primary endpoint. These patients were excluded from the primary endpoint analysis. Therefore, 14 participants were evaluated for each endpoint.

Reporting Groups
  Description
Treatment (Vorinostat, Bortezomib) Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Vorinostat, Bortezomib)  
STARTED     16  
COMPLETED     14  
NOT COMPLETED     2  
Protocol Violation                 2  



  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
Treatment (Vorinostat, Bortezomib) Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Vorinostat, Bortezomib)  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 34 to 81 )  
Gender  
[units: participants]
 
Female     11  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Confirmed Tumor Responses   [ Time Frame: Up to 2 years ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Up to 2 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Time from registration to death due to any cause, assessed up to 2 years ]


  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: Steven Attia, D.O.
Organization: University of Wisconsin
e-mail: sa2@medicine.wisc.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00937495     History of Changes
Other Study ID Numbers: NCI-2011-03810, MC0778, CDR0000646715, MAYO-MC0778, N01CM62205
Study First Received: July 10, 2009
Results First Received: September 11, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration