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Trial record 73 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00347919
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : February 21, 2011
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Drug: pazopanib (GW786034) 400 mg
Drug: lapatinib (GW572016) 1500 mg
Drug: lapatinib (GW572016) 1000 mg
Drug: pazopanib (GW786034) 800 mg
Enrollment 189
Recruitment Details Participants (par.) were enrolled into two cohorts. Cohort 1: Par. were randomized 1:1 to lapatinib 1500 mg or lapatinib 1000 mg/pazopanib 400 mg. Cohort 2: After enrollment was complete for Cohort 1, par. were enrolled to lapatinib 1500 mg/pazopanib 800 mg. All par. who received study drug are accounted for in the Participant Flow module.
Pre-assignment Details Female par. with >=18 years of age with histologically confirmed invasive breast cancer were enrolled in the study. Total 189 par. (Cohort 1, combination n = 76, lapatinib n = 73; Cohort 2, n = 40) received study drug.
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered orally once a day Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Period Title: Overall Study
Started 73 [1] 76 [1] 40 [1]
Completed 2 0 2
Not Completed 71 76 38
Reason Not Completed
Lost to Follow-up             11             13             0
Withdrawal by Subject             6             8             0
Physician Decision             1             1             0
Sponsor terminated study             15             10             16
Death             35             42             19
Par. Started Other Treatment             1             1             1
Missing             2             1             2
[1]
Safety Population
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg Total
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered orally once a day Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day Total of all reporting groups
Overall Number of Baseline Participants 72 69 36 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 69 participants 36 participants 177 participants
53.5  (11.20) 52.1  (12.76) 54.1  (12.93) 52.8  (11.97)
[1]
Measure Description: The data in the Participant Flow module are for the Safety Population, comprised of any participant who had received study drug. All of the Baseline data are from a more limited population: the Modified Intent-to-Treat Population (MITT), comprised of those participants who received study drug and who also were confirmed to be Human Epidermal growth factor Receptor 2 (ErbB2) positive by fluorescent in situ hybridization (FISH) analysis.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 69 participants 36 participants 177 participants
Female
72
 100.0%
69
 100.0%
36
 100.0%
177
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Males were excluded. All participants were female.
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 69 participants 36 participants 177 participants
African American/African Heritage 0 1 0 1
American Indian or Alaska Native 20 18 0 38
Asian 33 30 3 66
White 19 18 32 69
Other 0 1 0 1
Unknown 0 1 1 2
Child-Bearing Potential  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 69 participants 36 participants 177 participants
Post-Menopausal 49 46 22 117
Sterile (of child-bearing age) 3 2 5 10
Potentially able to bear children 20 21 9 50
1.Primary Outcome
Title Percentage of Participants With Progressive Disease at Week 12 in Cohort 1
Hide Description The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1: Modified Intent-to-Treat (ITT) Population (all randomized, centrally confirmed, ErbB2 FISH-positive participants).
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered orally once a day
Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
Overall Number of Participants Analyzed 72 69
Measure Type: Number
Unit of Measure: percentage of participants
Independently Evaluated 38.9 36.2
Investigator Evaluated 43.1 37.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Lapatinib 1500 mg, Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3724
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 2.7
Confidence Interval 90%
-11.0 to 16.3
Estimation Comments Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1: Lapatinib 1500 mg, Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2578
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 5.4
Confidence Interval 90%
-8.4 to 19.2
Estimation Comments Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)
2.Secondary Outcome
Title Overall Survival for Cohort 1
Hide Description Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.
Time Frame Randomization until death due to any cause (up to 106.43 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered orally once a day
Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Overall Number of Participants Analyzed 0 69 0
Median (95% Confidence Interval)
Unit of Measure: weeks
91.0
(69.4 to 91.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Lapatinib 1500 mg, Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7488
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Response at Week 12 for Cohort 1 and Cohort 2
Hide Description The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered orally once a day
Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Overall Number of Participants Analyzed 72 69 36
Measure Type: Number
Unit of Measure: percentage of participants
Complete response, IRC evaluated 0 0 0
Complete response, Investigator evaluated 1 0 0
Partial response, IRC evaluated 22 36 33
Partial response, Investigator evaluated 26 45 50
Stable disease, IRC evaluated 39 28 31
Stable disease, Investigator evaluated 29 17 14
Progressive disease, IRC evaluated 17 20 8
Progressive disease, Investigator evaluated 38 20 11
Unknown/missing, IRC evaluated 22 15 28
Unknown/missing, Investigator 6 17 25
4.Secondary Outcome
Title Duration of Response in Cohort 1
Hide Description Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.
Time Frame Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered orally once a day
Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Overall Number of Participants Analyzed 72 69 0
Median (Inter-Quartile Range)
Unit of Measure: weeks
27.1
(24.3 to 27.7)
24.3
(12.3 to 24.3)
5.Secondary Outcome
Title Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2
Hide Description Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.
Time Frame The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered orally once a day
Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Overall Number of Participants Analyzed 72 69 36
Median (95% Confidence Interval)
Unit of Measure: weeks
IRC Evaluated
8.1
(7.9 to 11.4)
8.3
(8.0 to 11.9)
8.3
(7.4 to 8.7)
Investigator Evaluated
8.0
(7.9 to 8.1)
8.1
(8.0 to 8.4)
8.0
(7.3 to 8.6)
6.Secondary Outcome
Title Percentage of Participants With Progressive Disease at Week 12
Hide Description The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 MITT Population
Arm/Group Title Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description:
Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: percentage of participants
PD+Missing+Unknown, IRC evaluated 36
PD+Missing+Unknown, Investigator Evaluated 36
Time Frame Study Entry until 28 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered orally once a day Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
All-Cause Mortality
Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/73 (13.70%)      18/76 (23.68%)      13/40 (32.50%)    
Blood and lymphatic system disorders       
Anaemia  1  0/73 (0.00%)  0 2/76 (2.63%)  2 0/40 (0.00%)  0
Febrile neutropenia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Thrombocytopenia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Cardiac disorders       
Left ventricular dysfunction  1  0/73 (0.00%)  0 2/76 (2.63%)  2 0/40 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1  2/73 (2.74%)  2 1/76 (1.32%)  1 3/40 (7.50%)  3
Oesophagitis  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
Vomiting  1  1/73 (1.37%)  1 0/76 (0.00%)  0 0/40 (0.00%)  0
Abdominal pain upper  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Colitis  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
General disorders       
Fatigue  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
Pyrexia  1  0/73 (0.00%)  0 1/76 (1.32%)  1 4/40 (10.00%)  4
Hepatobiliary disorders       
Cholecystitis  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Hepatic failure  1  1/73 (1.37%)  1 0/76 (0.00%)  0 0/40 (0.00%)  0
Immune system disorders       
Hypersensitivity  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
Infections and infestations       
Gastroenteritis  1  1/73 (1.37%)  1 1/76 (1.32%)  1 0/40 (0.00%)  0
Cellulitis  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Injury, poisoning and procedural complications       
Femoral neck fracture  1  1/73 (1.37%)  1 0/76 (0.00%)  0 0/40 (0.00%)  0
Upper limb fracture  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Investigations       
Ejection fraction decreased  1  0/73 (0.00%)  0 3/76 (3.95%)  3 2/40 (5.00%)  3
Alanine aminotransferase increased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Aspartate aminotransferase increased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Hepatic enzyme increased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Metabolism and nutrition disorders       
Dehydration  1  3/73 (4.11%)  3 0/76 (0.00%)  0 1/40 (2.50%)  1
Hyponatraemia  1  0/73 (0.00%)  0 1/76 (1.32%)  1 1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to central nervous system  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders       
Somnolence  1  1/73 (1.37%)  1 0/76 (0.00%)  0 0/40 (0.00%)  0
Dizziness  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders       
Hydronephrosis  1  0/73 (0.00%)  0 0/76 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/73 (2.74%)  2 1/76 (1.32%)  1 0/40 (0.00%)  0
Epistaxis  1  1/73 (1.37%)  1 0/76 (0.00%)  0 0/40 (0.00%)  0
Pleural effusion  1  1/73 (1.37%)  1 2/76 (2.63%)  2 0/40 (0.00%)  0
Pneumothorax  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
Vascular disorders       
Hypertension  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
Embolism  1  0/73 (0.00%)  0 1/76 (1.32%)  1 0/40 (0.00%)  0
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%
Cohort 1: Lapatinib 1500 mg Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   63/73 (86.30%)      71/76 (93.42%)      39/40 (97.50%)    
Blood and lymphatic system disorders       
Anaemia  1  4/73 (5.48%)  4 4/76 (5.26%)  10 0/40 (0.00%)  0
Leukopenia  1  0/73 (0.00%)  0 6/76 (7.89%)  8 2/40 (5.00%)  10
Neutropenia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  5
Thrombocytopenia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Cardiac disorders       
Left ventricular dysfunction  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Ear and labyrinth disorders       
Tinnitus  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Endocrine disorders       
Hypothyroidism  1  0/73 (0.00%)  0 6/76 (7.89%)  7 0/40 (0.00%)  0
Eye disorders       
Eye pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  3
Gastrointestinal disorders       
Abdominal distension  1  8/73 (10.96%)  8 3/76 (3.95%)  3 0/40 (0.00%)  0
Abdominal discomfort  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  3
Abdominal pain  1  3/73 (4.11%)  3 7/76 (9.21%)  7 11/40 (27.50%)  14
Abdominal pain upper  1  2/73 (2.74%)  3 7/76 (9.21%)  7 3/40 (7.50%)  4
Constipation  1  4/73 (5.48%)  4 0/76 (0.00%)  0 2/40 (5.00%)  2
Diarrhoea  1  41/73 (56.16%)  81 52/76 (68.42%)  172 34/40 (85.00%)  86
Dry mouth  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Dyspepsia  1  6/73 (8.22%)  9 8/76 (10.53%)  10 7/40 (17.50%)  8
Nausea  1  13/73 (17.81%)  18 23/76 (30.26%)  31 28/40 (70.00%)  35
Rectal haemorrhage  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Stomatitis  1  5/73 (6.85%)  6 5/76 (6.58%)  22 5/40 (12.50%)  7
Vomiting  1  6/73 (8.22%)  10 15/76 (19.74%)  28 13/40 (32.50%)  19
General disorders       
Asthenia  1  9/73 (12.33%)  13 9/76 (11.84%)  11 5/40 (12.50%)  5
Chest discomfort  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Chest pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 4/40 (10.00%)  4
Fatigue  1  7/73 (9.59%)  7 12/76 (15.79%)  18 23/40 (57.50%)  25
Mucosal inflammation  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  7
Infections and infestations       
Urinary tract infection  1  7/73 (9.59%)  8 4/76 (5.26%)  6 2/40 (5.00%)  2
Paronychia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  4
Investigations       
Alanine aminotransferase increased  1  13/73 (17.81%)  21 25/76 (32.89%)  39 15/40 (37.50%)  20
Aspartate aminotransferase increased  1  13/73 (17.81%)  16 26/76 (34.21%)  40 15/40 (37.50%)  22
Blood bilirubin increased  1  3/73 (4.11%)  4 10/76 (13.16%)  17 0/40 (0.00%)  0
Blood thyroid stimulating hormone increased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 7/40 (17.50%)  8
Platelet count decreased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  6
Crystal urine present  1  0/73 (0.00%)  0 5/76 (6.58%)  5 0/40 (0.00%)  0
Electrocardiogram QT prolonged  1  0/73 (0.00%)  0 4/76 (5.26%)  5 0/40 (0.00%)  0
Weight decreased  1  3/73 (4.11%)  4 8/76 (10.53%)  10 5/40 (12.50%)  6
Ejection fraction decreased  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Blood alkaline phosphatase increased  1  10/73 (13.70%)  10 9/76 (11.84%)  9 5/40 (12.50%)  6
Metabolism and nutrition disorders       
Hyponatraemia  1  0/73 (0.00%)  0 4/76 (5.26%)  11 0/40 (0.00%)  0
Hypokalaemia  2  0/73 (0.00%)  0 0/76 (0.00%)  0 4/40 (10.00%)  5
Decreased appetite  1  10/73 (13.70%)  12 17/76 (22.37%)  21 14/40 (35.00%)  21
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 6/40 (15.00%)  8
Back pain  1  5/73 (6.85%)  8 4/76 (5.26%)  4 5/40 (12.50%)  5
Musculoskeletal pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 4/40 (10.00%)  4
Myalgia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Neck pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Pain in extremity  1  8/73 (10.96%)  9 9/76 (11.84%)  13 4/40 (10.00%)  6
Musculoskeletal chest pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pyrexia  1  7/73 (9.59%)  10 6/76 (7.89%)  7 0/40 (0.00%)  0
Nervous system disorders       
Dizziness  1  6/73 (8.22%)  6 4/76 (5.26%)  5 7/40 (17.50%)  10
Dysgeusia  1  1/73 (1.37%)  1 12/76 (15.79%)  13 12/40 (30.00%)  12
Headache  1  7/73 (9.59%)  12 6/76 (7.89%)  14 11/40 (27.50%)  15
Neuropathy peripheral  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Psychiatric disorders       
Insomnia  1  1/73 (1.37%)  1 8/76 (10.53%)  10 5/40 (12.50%)  5
Depression  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Renal and urinary disorders       
Haematuria  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Proteinuria  1  2/73 (2.74%)  2 8/76 (10.53%)  12 0/40 (0.00%)  0
Reproductive system and breast disorders       
Breast pain  1  0/73 (0.00%)  0 0/76 (0.00%)  0 4/40 (10.00%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/73 (6.85%)  5 7/76 (9.21%)  8 2/40 (5.00%)  3
Dysphonia  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Epistaxis  1  4/73 (5.48%)  9 7/76 (9.21%)  10 13/40 (32.50%)  15
Oropharyngeal pain  1  4/73 (5.48%)  4 5/76 (6.58%)  5 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  3/73 (4.11%)  3 11/76 (14.47%)  13 10/40 (25.00%)  11
Dermatitis acneiform  1  3/73 (4.11%)  4 5/76 (6.58%)  5 2/40 (5.00%)  3
Dry skin  1  7/73 (9.59%)  7 5/76 (6.58%)  5 2/40 (5.00%)  2
Hair colour changes  1  0/73 (0.00%)  0 14/76 (18.42%)  14 11/40 (27.50%)  13
Nail disorder  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  3
Palmar-plantar erythrodysaesthesia syndrome  1  0/73 (0.00%)  0 0/76 (0.00%)  0 3/40 (7.50%)  4
Pruritus  1  10/73 (13.70%)  12 5/76 (6.58%)  5 4/40 (10.00%)  5
Rash  1  21/73 (28.77%)  30 21/76 (27.63%)  27 16/40 (40.00%)  26
Rash macular  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  2
Skin hypopigmentation  1  0/73 (0.00%)  0 4/76 (5.26%)  4 0/40 (0.00%)  0
Vascular disorders       
Hypertension  1  4/73 (5.48%)  7 20/76 (26.32%)  25 15/40 (37.50%)  25
Hot flush  1  0/73 (0.00%)  0 0/76 (0.00%)  0 2/40 (5.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, Hypokalaemia
In 2008 at primary completion, study was terminated. In 2011, protocol amendment 4 (Am4), allowed continuation of treatment until PD for the 1 par. This par. completed the study per Am 4. Par. last visit occurred, the study is considered completed.
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: NCT00347919     History of Changes
Other Study ID Numbers: VEG20007
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: November 19, 2009
Results First Posted: February 21, 2011
Last Update Posted: February 25, 2016