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A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00281632
First received: January 23, 2006
Last updated: March 17, 2011
Last verified: February 2011
History of Changes
Results First Received: November 25, 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
Conditions: Malignant Tumor of Peritoneum
Ovarian Cancer
Neoplasms, Ovarian
Fallopian Tube Cancer
Intervention: Drug: 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
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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 800 milligrams (mg) pazopanib administered orally once daily

Participant Flow:   Overall Study
    Pazopanib 800 mg  
STARTED     36  
COMPLETED     0 [1]
NOT COMPLETED     36  
Adverse Event                 7  
Withdrawal by Subject                 2  
Disease Progression                 22  
Death                 1  
Physician Decision                 1  
Ongoing                 3  
[1] Three participants were ongoing in the study at the time of the data cut-off (30 Apr 2008).



  Baseline Characteristics
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Reporting Groups
  Description
Pazopanib 800 mg 800 milligrams (mg) pazopanib administered orally once daily

Baseline Measures
    Pazopanib 800 mg  
Number of Participants  
[units: participants]
 		  36  
Age  
[units: years]
Mean ± Standard Deviation 		  59.9  ± 11.24  
Gender  
[units: participants]
 		 
Female     36  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 		 
Asian - South East Asian Heritage     2  
White - White/Caucasian/European Heritage     34  



  Outcome Measures
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1.  Primary:   Best Biochemical Response (Cancer Antigen [CA-125])   [ Time Frame: Baseline to response (up to 3 years) ]
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2.  Secondary:   Time to Biochemical Response (CA-125)   [ Time Frame: Baseline to response (up to 3 years) ]
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3.  Secondary:   Duration of Biochemical Response (CA-125)   [ Time Frame: Baseline to response (up to 3 years) ]
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4.  Secondary:   CA-125 Doubling Time Prior to and During Treatment With Pazopanib   [ Time Frame: Baseline to doubling of CA-125 (up to 3 years) ]
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5.  Secondary:   Overall Response and Stable Disease (SD)   [ Time Frame: Baseline to response (up to 3 years) ]
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6.  Secondary:   Median Progression-free Survival (PFS)   [ Time Frame: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years) ]
  Show Outcome Measure 6

7.  Secondary:   Overall Tumor Response   [ Time Frame: Baseline to response (up to 3 years) ]
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8.  Secondary:   Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure   [ Time Frame: Baseline to response (up to 3 years) ]
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9.  Secondary:   Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure   [ Time Frame: Baseline to response (up to 3 years) ]
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10.  Secondary:   Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate   [ Time Frame: Baseline to response (up to 3 years) ]
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11.  Secondary:   Mean Change From Baseline to Response in Albumin   [ Time Frame: Baseline to response (up to 3 years) ]
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12.  Secondary:   Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase   [ Time Frame: Baseline to response (up to 3 years) ]
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13.  Secondary:   Mean Change From Baseline to Response in Amylase and Lipase   [ Time Frame: Baseline to response (up to 3 years) ]
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14.  Secondary:   Mean Change From Baseline to Response in Total Bilirubin and Creatinine   [ Time Frame: Baseline to response (up to 3 years) ]
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15.  Secondary:   Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea   [ Time Frame: Baseline to response (up to 3 years) ]
  Show Outcome Measure 15

16.  Secondary:   Mean Change From Baseline to Response in Thyroxine   [ Time Frame: Baseline to response (up to 3 years) ]
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17.  Secondary:   Mean Change From Baseline to Response in Thyroid Stimulating Hormone   [ Time Frame: Baseline to response (up to 3 years) ]
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18.  Secondary:   Mean Change From Baseline to Response in Hemoglobin and Hematocrit   [ Time Frame: Baseline to response (up to 3 years) ]
  Show Outcome Measure 18

19.  Secondary:   Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count   [ Time Frame: Baseline to response (up to 3 years) ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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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.


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


Publications:
Friedlander M, Hancock KC, Rischin D, Messing M, Stringer CA, Matthys G, Ma B, Hodge JP, Lager JJ. A Phase II, Open-Label Study Evaluating Pazopanib in Patients With Advanced Ovarian Cancer . [Gynecol Oncol]. 2010;119(1):32-37.

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00281632     History of Changes
Other Study ID Numbers: 104450
Study First Received: January 23, 2006
Results First Received: November 25, 2009
Last Updated: March 17, 2011
Health Authority: Singapore: Health Sciences Authority
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration