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Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00297258
Recruitment Status : Completed
First Posted : February 28, 2006
Results First Posted : January 6, 2010
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma, Soft Tissue
Intervention Drug: pazopanib
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pazopanib 800 mg
Hide Arm/Group Description Pazopanib 800 milligram (mg) (tablets) administered orally once a day
Period Title: Overall Study
Started 142
Completed 0
Not Completed 142
Reason Not Completed
Disease Progression, Relapse, Death             120
Toxicity (or Toxic Death)             10
Patient Refusal: Not Related to Toxicity             2
Intercurrent Illness             3
Intercurrent Death             2
Deteriorization of General Condition             1
Radiotherapy to Destroy Last Lesion             1
Surgery Performed on Target Lesion             1
Switch to Commercial Treatment             1
Interruption: Cold/Flu-like Symptoms             1
Arm/Group Title Pazopanib 800 mg
Hide Arm/Group Description Pazopanib 800 milligram (mg) (tablets) administered orally once a day
Overall Number of Baseline Participants 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 142 participants
51.0
(18 to 79)
[1]
Measure Description: Includes all participants enrolled in the study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Female
71
  50.0%
Male
71
  50.0%
1.Primary Outcome
Title Progression Free Survival at Week 12
Hide Description Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a >=20% increase in target lesions.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken >=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Arm/Group Title Pazopanib 800 mg - Adipocytic Tumors Pazopanib 800 mg - Leiomyosarcoma Pazopanib 800 mg - Synovial Sarcoma Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
Hide Arm/Group Description:
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Overall Number of Participants Analyzed 19 41 37 41
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 0 0
Partial Response 0 1 4 1
Stable Disease 5 16 14 16
Progressive Disease 13 19 15 21
Unknown 0 2 0 1
Missing 1 3 4 2
CR+PR+SD 5 17 18 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pazopanib 800 mg - Adipocytic Tumors
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.653
Comments [Not Specified]
Method binomial exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 46
Confidence Interval 90%
11.0 to 47.6
Estimation Comments The estimated value represents the percentage of participants with a CR, a PR, or SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pazopanib 800 mg - Leiomyosarcoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method binomial exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 41
Confidence Interval 90%
28.4 to 55.5
Estimation Comments The estimated value represents the percentage of participants with a CR, a PR, or SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pazopanib 800 mg - Synovial Sarcoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method binomial exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 49
Confidence Interval 90%
34.3 to 63.2
Estimation Comments The estimated value represents the percentage of participants with a CR, a PR, or SD.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method binomial exact method
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 41
Confidence Interval 90%
28.4 to 55.5
Estimation Comments The estimated value represents the percentage of participants with a CR, a PR, or SD.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.
Time Frame Start of therapy until death (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Arm/Group Title Pazopanib 800 mg - Adipocytic Tumors Pazopanib 800 mg - Leiomyosarcoma Pazopanib 800 mg - Synovial Sarcoma Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
Hide Arm/Group Description:
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Overall Number of Participants Analyzed 19 41 37 41
Median (90% Confidence Interval)
Unit of Measure: years
28.1
(18.3 to 84.0)
50.9
(46.1 to 76.4)
44.6
(33.0 to 57.6)
42.6
(33.1 to 49.3)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.
Time Frame Start of therapy until progression (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Arm/Group Title Pazopanib 800 mg - Adipocytic Tumors Pazopanib 800 mg - Leiomyosarcoma Pazopanib 800 mg - Synovial Sarcoma Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
Hide Arm/Group Description:
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Overall Number of Participants Analyzed 19 41 37 41
Median (90% Confidence Interval)
Unit of Measure: years
11.1
(7.1 to 11.9)
17.2
(12.0 to 24.1)
23.4
(11.7 to 29.3)
14.0
(12.0 to 36.3)
4.Secondary Outcome
Title Overall Response
Hide Description Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.
Time Frame Baseline until either response or progression (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Arm/Group Title Pazopanib 800 mg - Adipocytic Tumors Pazopanib 800 mg - Leiomyosarcoma Pazopanib 800 mg - Synovial Sarcoma Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
Hide Arm/Group Description:
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Pazopanib 800 mg (tablets) administered orally once a day
Overall Number of Participants Analyzed 19 41 37 41
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 0 0
Partial Response 0 1 4 3
Stable Disease 5 17 14 14
Progressive Disease 13 19 13 21
Unknown 1 4 6 3
Missing 0 0 0 0
Time Frame Entire Study (average of 8.24 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pazopanib 800 mg
Hide Arm/Group Description Pazopanib 800 milligram (mg) (tablets) administered orally once a day
All-Cause Mortality
Pazopanib 800 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pazopanib 800 mg
Affected / at Risk (%)
Total   39/142 (27.46%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation  1  1/142 (0.70%) 
Haemolysis  1  1/142 (0.70%) 
Cardiac disorders   
Coronary artery disease  1  1/142 (0.70%) 
Eye disorders   
Vision blurred  1  1/142 (0.70%) 
Gastrointestinal disorders   
Abdominal pain  1  1/142 (0.70%) 
Diarrhoea  1  3/142 (2.11%) 
Vomiting  1  3/142 (2.11%) 
Abdominal distension  1  1/142 (0.70%) 
Abdominal pain upper  1  1/142 (0.70%) 
Duodenal ulcer  1  1/142 (0.70%) 
Gastrointestinal haemorrhage  1  1/142 (0.70%) 
Gingivitis  1  1/142 (0.70%) 
Ileal perforation  1  1/142 (0.70%) 
Peritonitis  1  1/142 (0.70%) 
Small intestinal perforation  1  1/142 (0.70%) 
General disorders   
General physical health deterioration  1  2/142 (1.41%) 
Chest pain  1  2/142 (1.41%) 
Fatigue  1  2/142 (1.41%) 
Pyrexia  1  1/142 (0.70%) 
Ill-defined disorder  1  1/142 (0.70%) 
Oedema  1  1/142 (0.70%) 
Infections and infestations   
Pnuemonia  1  2/142 (1.41%) 
Lower respiratory tract infection  1  1/142 (0.70%) 
Sepsis  1  1/142 (0.70%) 
Injury, poisoning and procedural complications   
Fall  1  1/142 (0.70%) 
Laceration  1  1/142 (0.70%) 
Multiple fractures  1  1/142 (0.70%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/142 (0.70%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/142 (1.41%) 
Musculoskeletal pain  1  1/142 (0.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  1/142 (0.70%) 
Nervous system disorders   
Somnolence  1  1/142 (0.70%) 
Syncope  1  1/142 (0.70%) 
Psychiatric disorders   
Depression  1  1/142 (0.70%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  5/142 (3.52%) 
Dyspnoea  1  1/142 (0.70%) 
Pleuritic pain  1  1/142 (0.70%) 
Pulmonary embolism  1  1/142 (0.70%) 
Pulmonary haemorrhage  1  1/142 (0.70%) 
Respiratory failure  1  1/142 (0.70%) 
Vascular disorders   
Embolism  1  5/142 (3.52%) 
Hypertension  1  3/142 (2.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pazopanib 800 mg
Affected / at Risk (%)
Total   137/142 (96.48%) 
Gastrointestinal disorders   
Diarrhoea  1  62/142 (43.66%) 
Nausea  1  60/142 (42.25%) 
Vomiting  1  48/142 (33.80%) 
Constipation  1  33/142 (23.24%) 
Abdominal pain  1  27/142 (19.01%) 
Stomatitis  1  18/142 (12.68%) 
Abdominal pain upper  1  14/142 (9.86%) 
Abdominal distension  1  12/142 (8.45%) 
General disorders   
Fatigue  1  84/142 (59.15%) 
Oedema  1  21/142 (14.79%) 
Chest pain  1  17/142 (11.97%) 
Pyrexia  1  17/142 (11.97%) 
Metabolism and nutrition disorders   
Decreased appetite  1  45/142 (31.69%) 
Weight decreased  1  45/142 (31.69%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  32/142 (22.54%) 
Back pain  1  15/142 (10.56%) 
Arthralgia  1  9/142 (6.34%) 
Pain in extremity  1  8/142 (5.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  51/142 (35.92%) 
Nervous system disorders   
Headache  1  30/142 (21.13%) 
Dysgeusia  1  13/142 (9.15%) 
Dizziness  1  12/142 (8.45%) 
Peripheral sensory neuropathy  1  9/142 (6.34%) 
Psychiatric disorders   
Anxiety  1  13/142 (9.15%) 
Insomnia  1  11/142 (7.75%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  33/142 (23.24%) 
Dyspnoea  1  31/142 (21.83%) 
Epistaxis  1  8/142 (5.63%) 
Skin and subcutaneous tissue disorders   
Skin hypopigmentation  1  53/142 (37.32%) 
Exfoliative rash  1  23/142 (16.20%) 
Dry skin  1  10/142 (7.04%) 
Alopecia  1  9/142 (6.34%) 
Hyperhidrosis  1  9/142 (6.34%) 
Vascular disorders   
Hypertension  1  57/142 (40.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297258     History of Changes
Obsolete Identifiers: NCT00293449
Other Study ID Numbers: VEG20002
First Submitted: February 24, 2006
First Posted: February 28, 2006
Results First Submitted: December 2, 2009
Results First Posted: January 6, 2010
Last Update Posted: February 3, 2016