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Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00297258
Recruitment Status : Completed
First Posted : February 28, 2006
Results First Posted : January 6, 2010
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sarcoma, Soft Tissue
Intervention: Drug: pazopanib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Pazopanib 800 mg Pazopanib 800 milligram (mg) (tablets) administered orally once a day

Participant Flow:   Overall Study
    Pazopanib 800 mg
STARTED   142 
COMPLETED   0 
NOT COMPLETED   142 
Disease Progression, Relapse, Death                120 
Toxicity (or Toxic Death)                10 
Patient Refusal: Not Related to Toxicity                2 
Intercurrent Illness                3 
Intercurrent Death                2 
Deteriorization of General Condition                1 
Radiotherapy to Destroy Last Lesion                1 
Surgery Performed on Target Lesion                1 
Switch to Commercial Treatment                1 
Interruption: Cold/Flu-like Symptoms                1 



  Baseline Characteristics

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
Pazopanib 800 mg Pazopanib 800 milligram (mg) (tablets) administered orally once a day

Baseline Measures
   Pazopanib 800 mg 
Overall Participants Analyzed 
[Units: Participants]
 142 
Age [1] 
[Units: Years]
Median (Full Range)
 51.0 
 (18 to 79) 
[1] Includes all participants enrolled in the study
Gender 
[Units: Participants]
 
Female   71 
Male   71 


  Outcome Measures

1.  Primary:   Progression Free Survival at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Overall Survival   [ Time Frame: Start of therapy until death (up to approximately 5 years) ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Start of therapy until progression (up to approximately 5 years) ]

4.  Secondary:   Overall Response   [ Time Frame: Baseline until either response or progression (up to approximately 5 years) ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297258     History of Changes
Obsolete Identifiers: NCT00293449
Other Study ID Numbers: VEG20002
First Submitted: February 24, 2006
First Posted: February 28, 2006
Results First Submitted: December 2, 2009
Results First Posted: January 6, 2010
Last Update Posted: February 3, 2016