Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00731211
First received: August 5, 2008
Last updated: May 18, 2015
Last verified: May 2015
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Intervention: Drug: Pazopanib

  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
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 of pazopanib orally each day continuously

Pazopanib: 800 mg of pazopanib orally each day continuously


Participant Flow:   Overall Study
    Pazopanib  
STARTED     55 [1]
COMPLETED     55  
NOT COMPLETED     0  
[1] 2 patients ineligible (papillary histologic type-1 pt. Previous treatment with everolimus alone-1 pt



  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.
All eligible patients

Reporting Groups
  Description
Pazopanib

800 mg of pazopanib orally each day continuously

Pazopanib: 800 mg of pazopanib orally each day continuously


Baseline Measures
    Pazopanib  
Number of Participants  
[units: participants]
  55  
Age  
[units: years]
Median (Full Range)
  60   (41 to 82)  
Gender  
[units: participants]
 
Female     13  
Male     42  
Region of Enrollment  
[units: participants]
 
United States     55  



  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: 18 months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: every 8 weeks until progressive disease, expected average of 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 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: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00731211     History of Changes
Other Study ID Numbers: SCRI GU 56
Study First Received: August 5, 2008
Results First Received: December 16, 2014
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration