Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549328
First received: October 23, 2007
Last updated: October 16, 2014
Last verified: November 2011
Results First Received: December 22, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer, Non-Small Cell
Intervention: Drug: Pazopanib (GW786034)

  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 Pazopanib 800 milligrams (mg) monotherapy given orally once daily

Participant Flow:   Overall Study
    Pazopanib 800 mg  
STARTED     14  
COMPLETED     0  
NOT COMPLETED     14  
Adverse Event                 2  
Disease Progression                 10  
Death                 1  
Use of Prohibited Medication                 1  



  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
Pazopanib 800 mg Pazopanib 800 milligrams (mg) monotherapy given orally once daily

Baseline Measures
    Pazopanib 800 mg  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Mean ± Standard Deviation
  63.6  ± 7.97  
Gender  
[units: participants]
 
Female     7  
Male     7  
Race/Ethnicity, Customized  
[units: participants]
 
White     14  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria   [ Time Frame: Baseline through End of Study (up to 2 years) ]

2.  Secondary:   Number of Participants Who Had a Complete or Partial Response, or Stable Disease   [ Time Frame: Baseline through End of Study (up to 2 years) ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Baseline through End of Study (up to 2 years) ]

4.  Secondary:   Overall Survival   [ Time Frame: Baseline through End of Study (up to 2 years) ]

5.  Secondary:   Levels of Circulating Biomarkers in Plasma   [ Time Frame: Baseline through End of Study (up to 2 years) ]

6.  Secondary:   Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers   [ Time Frame: Baseline through End of Study (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 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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549328     History of Changes
Other Study ID Numbers: 109609
Study First Received: October 23, 2007
Results First Received: December 22, 2009
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration