Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01227928
First received: October 21, 2010
Last updated: July 3, 2014
Last verified: March 2014
Results First Received: April 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Neoplasms, Ovarian
Interventions: Drug: Pazopanib
Drug: Placebo comparator

  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
Placebo Participants received matching placebo administered orally once daily for up to 24 months.
Pazopanib 800 Milligrams Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.

Participant Flow:   Overall Study
    Placebo     Pazopanib 800 Milligrams  
STARTED     72     73  
Ongoing     64     67  
COMPLETED     5     4  
NOT COMPLETED     67     69  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 2  
Ongoing                 64                 67  



  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
Placebo Participants received matching placebo administered orally once daily for up to 24 months.
Pazopanib 800 Milligrams Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
Total Total of all reporting groups

Baseline Measures
    Placebo     Pazopanib 800 Milligrams     Total  
Number of Participants  
[units: participants]
  72     73     145  
Age  
[units: Years]
Mean ± Standard Deviation
  54.1  ± 10.46     51.7  ± 9.62     52.9  ± 10.09  
Gender  
[units: Participants]
     
Female     72     73     145  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     72     73     145  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months) ]

2.  Secondary:   Overall Survival   [ Time Frame: From randomization until death due to any cause (average of 15.2 months) ]

3.  Secondary:   PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria   [ Time Frame: From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months) ]

4.  Secondary:   Number of Participants With Any Dose Reduction or Any Dose Interruption   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

5.  Secondary:   Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

6.  Secondary:   Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

7.  Secondary:   Number of Participants With Any Grade 3 or 4 AE   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

8.  Secondary:   Number of Participants With the Indicated On-therapy Grade 3-5 AEs   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

9.  Secondary:   Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

10.  Secondary:   Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

11.  Secondary:   Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

12.  Secondary:   Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

13.  Secondary:   Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

14.  Secondary:   Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]

15.  Secondary:   Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2   [ Time Frame: From Week 1 until the end of the treatment period (up to Study Week 108) ]


  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: NCT01227928     History of Changes
Other Study ID Numbers: 114012
Study First Received: October 21, 2010
Results First Received: April 18, 2013
Last Updated: July 3, 2014
Health Authority: China: Food and Drug Administration
Taiwan: Department of Health
Hong Kong: Department of Health
South Korea: Food and Drug Administration