GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244764
First received: October 25, 2005
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: November 19, 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: Carcinoma, Renal Cell
Interventions: Drug: GW786034
Drug: Placebo

  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
This study was originally designed as a Phase II, multi-centre study utilizing a randomized discontinuation design. In the original study design, a 12-week Lead-in Phase was an open-label period during which all enrolled participans received pazopanib.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants began with 12 weeks of open-label treatment. In the original design, participants with stable disease at Week 12 were to be randomized. After the interim analysis, the study was amended to be treated like a single-arm open-label study. Any participants who had been randomized to placebo were to be crossed back to pazopanib.

Reporting Groups
  Description
Pazopanib 800 mg Pazopanib 800 milligrams (mg) (tablets) administered orally once a day

Participant Flow:   Overall Study
    Pazopanib 800 mg  
STARTED     225  
COMPLETED     129  
NOT COMPLETED     96  
Adverse Event                 37  
Lost to Follow-up                 23  
Withdrawal by Subject                 12  
Disease Progression                 13  
Protocol Violation                 2  
Death                 1  
Off Study Medication for >21 Days                 1  
Declining Performance Status                 1  
Participant was Hospitalized until Death                 1  
Primary Investigator Discretion                 2  
Sponsor Terminated Study                 2  
Developed Secondary Malignancy                 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.
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Reporting Groups
  Description
Pazopanib 800 mg Pazopanib 800 milligrams (mg) (tablets) administered orally once a day

Baseline Measures
    Pazopanib 800 mg  
Number of Participants  
[units: participants]
  225  
Age  
[units: years]
Mean ± Standard Deviation
  59.8  ± 10.33  
Gender  
[units: participants]
 
Female     69  
Male     156  
Race/Ethnicity, Customized  
[units: participants]
 
White     178  
Asian-Japanese/East Asian/South East Asian HER     38  
African American/African Heritage (HER)     4  
Asian-Central/South Asian Heritage     2  
American Indian or Alaska Native and White     1  
Asian-Mixed Asian Heritage     1  
Native Hawaiian or other Pacific Islander     1  



  Outcome Measures
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1.  Primary:   Overall Response by RECIST Criteria   [ Time Frame: Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter. ]

2.  Primary:   Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants   [ Time Frame: Week 12 ]

3.  Secondary:   Duration of Response   [ Time Frame: First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter. ]

4.  Secondary:   Progression-free Survival   [ Time Frame: From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244764     History of Changes
Other Study ID Numbers: VEG102616
Study First Received: October 25, 2005
Results First Received: November 19, 2009
Last Updated: August 11, 2014
Health Authority: Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
European Union: European Medicines Agency
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Malaysia: Ministry of Health
Taiwan: Department of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
United States: Food and Drug Administration