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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: August 15, 2013
Last verified: August 2013
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
No text entered.

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 - in Follow-up     15     31  
COMPLETED     0     0  
NOT COMPLETED     123     246  
Death                 102                 203  
Missing                 4                 9  
Participant Withdrew Consent                 2                 2  
Ongoing - in Follow-up                 15                 31  
Adverse Event                 0                 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
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) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of randomization until 215 deaths (assessed for an average of 12 months) ]

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) ]

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) ]

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) ]

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) ]

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 ]

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 ]

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) ]

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) ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title 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
Measure Description Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.
Time Frame From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)  
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]
  123     239  
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  
[units: participants]
   
ALKP, Any Increase, n=123, 237     28     77  
ALKP, Increase to Grade 3, n=123, 237     1     7  
ALKP, Increase to Grade 4, n=123, 237     0     0  
ALT, Any Increase, n=123, 237     22     110  
ALT, Increase to Grade 3, n=123, 237     3     18  
ALT, Increase to Grade 4, n=123, 237     1     5  
AST, Any Increase, n=123, 239     27     122  
AST, Increase to Grade 3, n=123, 239     2     13  
AST, Increase to Grade 4, n=123, 239     0     6  
Albumin, Any Increase, n=123, 239     26     81  
Albumin, Increase to Grade 3, n=123, 239     0     2  
Albumin, Increase to Grade 4, n=123, 239     0     0  
Creatinine, Any Increase, n=123, 239     9     28  
Creatinine, Increase to Grade 3, n=123, 239     0     1  
Creatinine, Increase to Grade 4, n=123, 239     0     0  
Hyperglycemia, Any Increase, n=122, 238     43     106  
Hyperglycemia, Increase to Grade 3, n=122, 238     2     1  
Hyperglycemia, Increase to Grade 4, n=122, 238     0     0  
Hyperkalemia, Any Increase, n=123, 238     13     37  
Hyperkalemia, Increase to Grade 3, n=123, 238     0     3  
Hyperkalemia, Increase to Grade 4, n=123, 238     0     0  
Hypernatremia, Any Increase, n=123, 238     3     10  
Hypernatremia, Increase to Grade 3, n=123, 238     0     0  
Hypernatremia, Increase to Grade 4, n=123, 238     0     0  
Hypoglycemia, Any Increase, n=122, 238     4     21  
Hypoglycemia, Increase to Grade 3, n=122, 238     0     1  
Hypoglycemia, Increase to Grade 4, n=122, 238     0     0  
Hypokalemia, Any Increase, n=123, 238     11     32  
Hypokalemia, Increase to Grade 3, n=123, 238     1     6  
Hypokalemia, Increase to Grade 4, n=123, 238     0     1  
Hyponatremia, Any Increase, n=123, 238     25     74  
Hyponatremia, Increase to Grade 3, n=123, 238     4     9  
Hyponatremia, Increase to Grade 4, n=123, 238     0     0  
Total Bilirubin, Any Increase, n=122, 237     9     68  
Total Bilirubin, Increase to Grade 3, n=122, 237     2     3  
Total Bilirubin, Increase to Grade 4, n=122, 237     0     0  

No statistical analysis provided for 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



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) ]


  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 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: August 15, 2013
Health Authority: United States: Food and Drug Administration