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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 
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
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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) ]

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
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Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from Baseline through End of Study (average of 20 study weeks).
Additional Description The Safety Population, comprised of all participants who had started their allocated treatment (at least one dose of the study drug), was used for all safety analyses.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Placebo   Pazopanib
Total, other (not including serious) adverse events     
# participants affected / at risk   108/123 (87.80%)   232/240 (96.67%) 
Cardiac disorders     
Left ventricular dysfunction † 1     
# participants affected / at risk   5/123 (4.07%)   19/240 (7.92%) 
Endocrine disorders     
Hypothyroidism † 1     
# participants affected / at risk   0/123 (0.00%)   20/240 (8.33%) 
Eye disorders     
Vision blurred † 1     
# participants affected / at risk   2/123 (1.63%)   12/240 (5.00%) 
Gastrointestinal disorders     
Nausea † 1     
# participants affected / at risk   27/123 (21.95%)   135/240 (56.25%) 
Diarrhea † 1     
# participants affected / at risk   19/123 (15.45%)   141/240 (58.75%) 
Vomiting † 1     
# participants affected / at risk   14/123 (11.38%)   81/240 (33.75%) 
Gastrointestinal pain † 1     
# participants affected / at risk   11/123 (8.94%)   57/240 (23.75%) 
Constipation † 1     
# participants affected / at risk   21/123 (17.07%)   39/240 (16.25%) 
Stomatitis † 1     
# participants affected / at risk   4/123 (3.25%)   27/240 (11.25%) 
Abdominal pain upper † 1     
# participants affected / at risk   7/123 (5.69%)   19/240 (7.92%) 
Dry mouth † 1     
# participants affected / at risk   6/123 (4.88%)   16/240 (6.67%) 
Dyspepsia † 1     
# participants affected / at risk   2/123 (1.63%)   18/240 (7.50%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   59/123 (47.97%)   157/240 (65.42%) 
Edema peripheral † 1     
# participants affected / at risk   11/123 (8.94%)   33/240 (13.75%) 
Pyrexia † 1     
# participants affected / at risk   12/123 (9.76%)   25/240 (10.42%) 
Chest pain † 1     
# participants affected / at risk   7/123 (5.69%)   26/240 (10.83%) 
Chills † 1     
# participants affected / at risk   1/123 (0.81%)   14/240 (5.83%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   7/123 (5.69%)   13/240 (5.42%) 
Investigations     
Weight decreased † 1     
# participants affected / at risk   9/123 (7.32%)   122/240 (50.83%) 
Ear, nose and throat examination abnormal † 1     
# participants affected / at risk   3/123 (2.44%)   29/240 (12.08%) 
Weight increased † 1     
# participants affected / at risk   9/123 (7.32%)   12/240 (5.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1     
# participants affected / at risk   23/123 (18.70%)   97/240 (40.42%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain † 1     
# participants affected / at risk   24/123 (19.51%)   56/240 (23.33%) 
Myalgia † 1     
# participants affected / at risk   11/123 (8.94%)   56/240 (23.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain † 1     
# participants affected / at risk   26/123 (21.14%)   71/240 (29.58%) 
Nervous system disorders     
Dysgeusia † 1     
# participants affected / at risk   4/123 (3.25%)   66/240 (27.50%) 
Headache † 1     
# participants affected / at risk   10/123 (8.13%)   57/240 (23.75%) 
Dizziness † 1     
# participants affected / at risk   5/123 (4.07%)   26/240 (10.83%) 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   10/123 (8.13%)   22/240 (9.17%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   7/123 (5.69%)   24/240 (10.00%) 
Anxiety † 1     
# participants affected / at risk   8/123 (6.50%)   20/240 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1     
# participants affected / at risk   21/123 (17.07%)   49/240 (20.42%) 
Cough † 1     
# participants affected / at risk   15/123 (12.20%)   43/240 (17.92%) 
Dysphonia † 1     
# participants affected / at risk   3/123 (2.44%)   18/240 (7.50%) 
Epistaxis † 1     
# participants affected / at risk   2/123 (1.63%)   19/240 (7.92%) 
Skin and subcutaneous tissue disorders     
Hair color changes † 1     
# participants affected / at risk   3/123 (2.44%)   93/240 (38.75%) 
Exfoliative rash † 1     
# participants affected / at risk   11/123 (8.94%)   46/240 (19.17%) 
Alopecia † 1     
# participants affected / at risk   1/123 (0.81%)   29/240 (12.08%) 
Skin disorder † 1     
# participants affected / at risk   1/123 (0.81%)   28/240 (11.67%) 
Skin hypopigmentation † 1     
# participants affected / at risk   0/123 (0.00%)   28/240 (11.67%) 
Dry skin † 1     
# participants affected / at risk   1/123 (0.81%)   16/240 (6.67%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   7/123 (5.69%)   101/240 (42.08%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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