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Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy (PALETTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00753688
First received: September 12, 2008
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
Results First Received: November 17, 2011  
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: Sarcoma, Soft Tissue
Interventions: Drug: PAZOPANIB
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
Pazopanib Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Participant Flow:   Overall Study
    Placebo     Pazopanib  
STARTED     123     246  
Ongoing     42     99  
COMPLETED     0     0  
NOT COMPLETED     123     246  
Death                 78                 137  
Missing                 2                 7  
Participant Withdrew Consent                 1                 2  
Adverse Event                 0                 1  
Ongoing                 42                 99  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
Pazopanib Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
Total Total of all reporting groups

Baseline Measures
    Placebo     Pazopanib     Total  
Number of Participants  
[units: participants]
 		  123     246     369  
Age  
[units: Years]
Mean ± Standard Deviation 		  51.7  ± 13.77     54.0  ± 14.92     53.2  ± 14.57  
Gender  
[units: Participants]
 		     
Female     69     147     216  
Male     54     99     153  
Race/Ethnicity, Customized  
[units: participants]
 		     
African American/African Heritage     2     4     6  
American Indian or Alaska Native     0     1     1  
Asian - Central/South Asian Heritage     2     0     2  
Asian - East Asian Heritage     7     24     31  
Asian - Japanese Heritage     16     31     47  
Asian - South East Asian Heritage     2     2     4  
White - Arabic/North African Heritage     2     1     3  
White - White/Caucasian/European Heritage     89     174     263  
Mixed Race     1     0     1  
Unknown     2     9     11  
Number of participants in the indicated soft tissue sarcoma (STS) subgroups at Baseline [1]
[units: participants]
 		     
Leiomyosarcoma     49     109     158  
Synovial sarcoma     13     25     38  
Other STS histologies     61     112     173  
[1] Participants were categorized in the following histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma, defined as malignant cancer of smooth muscle; synovial sarcoma, defined as cancer near the joints of the arm or leg; and other STS, defined as sarcoma without the tumor type of leiomyosarcoma or synovial sarcoma.



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of randomization until 215 deaths (assessed for an average of 10 months) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator   [ Time Frame: From the start of treatment until disease progression (assessed for an average of 10 months) ]
  Show Outcome Measure 3

4.  Secondary:   Time to Response Assessed by an Independent Radiologist and the Investigator   [ Time Frame: From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Response Assessed by the Independent Radiologist and the Investigator   [ Time Frame: From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) ]
  Show Outcome Measure 5

6.  Secondary:   PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)   [ Time Frame: From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Heart Rate   [ Time Frame: Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Change From Baseline in Heart Rate
Measure Description Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.
Time Frame Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104  
Safety Issue No  

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.
Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.

Reporting Groups
  Description
Placebo Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
Pazopanib Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Measured Values
    Placebo     Pazopanib  
Number of Participants Analyzed  
[units: participants]
 		  113     225  
Change From Baseline in Heart Rate  
[units: beats per minute]
Mean ± Standard Deviation 		   
Day 8, n=113, 225     1.6  ± 12.61     -4.4  ± 11.24  
Week 4, n=98, 208     3.1  ± 13.06     -2.7  ± 13.51  
Week 8, n=66, 171     2.1  ± 15.03     -1.6  ± 14.31  
Week 12, n=29, 103     1.1  ± 17.32     -2.4  ± 11.67  
Week 16, n=31, 127     6.0  ± 16.78     -3.7  ± 12.76  
Week 20, n=12, 57     0.6  ± 22.95     -3.4  ± 11.71  
Week 24, n=21, 94     4.5  ± 18.14     -5.0  ± 12.83  
Week 28, n=7, 37     -1.1  ± 27.99     -3.8  ± 13.68  
Week 32, n=12, 72     -1.7  ± 18.38     -2.7  ± 12.63  
Week 36, n=5, 24     -11.8  ± 32.57     0.9  ± 13.37  
Week 40, n=5, 58     -8.2  ± 30.19     -2.4  ± 12.84  
Week 44, n=3, 15     7.0  ± 16.09     -0.9  ± 14.02  
Week 48, n=3, 33     9.0  ± 18.00     1.9  ± 14.38  
Week 52, n=1, 5     -8.0  ± NA [1]   -3.4  ± 16.96  
Week 56, n=1, 24     31.0  ± NA [1]   -0.4  ± 15.14  
Week 60, n=0, 6     NA  ± NA [2]   4.3  ± 15.13  
Week 64, n=1, 13     36.0  ± NA [1]   -1.5  ± 13.56  
Week 68, n=0, 2     NA  ± NA [2]   9.5  ± 0.71  
Week 72, n=1, 8     14.0  ± NA [1]   2.6  ± 12.60  
Week 76, n=0, 1     NA  ± NA [2]   5.0  ± NA [1]
Week 80, n=1, 5     24.0  ± NA [1]   2.8  ± 16.08  
Week 88, n=1, 3     9.0  ± NA [1]   -3.0  ± 10.58  
Week 96, n=1, 2     17.0  ± NA [1]   -5.0  ± 4.24  
Week 104, n=1, 1     30.0  ± NA [1]   1.0  ± NA [1]
[1] Only one participant was analyzed in this group at this time point; therefore, no SD is being reported.
[2] No participants were analyzed in this group at this time point.

No statistical analysis provided for Change From Baseline in Heart Rate



9.  Secondary:   Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count   [ Time Frame: From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin   [ Time Frame: From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)   [ Time Frame: Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) ]
  Show Outcome Measure 11


  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
No text entered.  


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00753688     History of Changes
Obsolete Identifiers: NCT00794521
Other Study ID Numbers: VEG110727
Study First Received: September 12, 2008
Results First Received: November 17, 2011
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration