Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 
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
  Hide 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.


  More Information