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Trial record 39 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00320411
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : December 14, 2009
Last Update Posted : January 31, 2019
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 Neoplasms, Breast
Intervention Drug: lapatinib
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib Monotherapy
Hide Arm/Group Description Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Period Title: Overall Study
Started 62
Completed 58
Not Completed 4
Reason Not Completed
No investigational product admin.             4
Arm/Group Title Lapatinib Monotherapy
Hide Arm/Group Description Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
54.6  (8.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
58
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 58 participants
58
1.Primary Outcome
Title Overall Tumor Response
Hide Description Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.
Time Frame Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
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Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Complete response 1
Partial response 8
Stable disease 18
Progressive disease 29
Unknown 2
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.
Time Frame First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
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Participants who achieved defined efficacy
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: weeks
20.6
(16.1 to 32.1)
3.Secondary Outcome
Title Time to Progression
Hide Description Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.
Time Frame Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.
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ITT Population
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Median (Inter-Quartile Range)
Unit of Measure: weeks
8.4
(7.4 to 23.9)
4.Secondary Outcome
Title Clinical Benefit
Hide Description Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.
Time Frame Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.
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ITT Population
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
17.2
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Statistical Analysis Overview Comparison Group Selection Lapatinib Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 17.2
Confidence Interval 95%
8.6 to 29.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).
Time Frame Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.
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Hide Analysis Population Description
Participants in the ITT Population achieving a partial or complete response
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Days
111
(56 to 279)
6.Secondary Outcome
Title 4-month Progression Free Survival
Hide Description The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.
Time Frame Baseline to Month 4 (Week 16)
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ITT Population
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
32.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 32.3
Confidence Interval 95%
20.0 to 44.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 6-month Progression Free Survival
Hide Description The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.
Time Frame Baseline to Month 6 (Week 24)
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ITT Population
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
22.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 22.8
Confidence Interval 95%
11.6 to 34.0
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured as the time between the start of dosing until death, regardless of cause.
Time Frame Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.
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Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 58
Median (Inter-Quartile Range)
Unit of Measure: weeks
43.1
(24.3 to 80.7)
9.Secondary Outcome
Title Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants
Hide Description Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
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Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation.
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.9  (26.32)
10.Secondary Outcome
Title Mean p-BAD H Score for All Participants
Hide Description Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
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Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.8  (36.50)
11.Secondary Outcome
Title Mean Bcl-2 H Score for All Participants
Hide Description Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
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Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.9  (47.82)
12.Secondary Outcome
Title Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants
Hide Description Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
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Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
185.5  (50.61)
13.Secondary Outcome
Title Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants
Hide Description Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
133.3  (60.47)
14.Secondary Outcome
Title Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants
Hide Description Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.2  (17.30)
15.Secondary Outcome
Title Mean Heregulin H Score for All Participants
Hide Description Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.3  (42.37)
16.Secondary Outcome
Title Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants
Hide Description Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
153.5  (48.44)
17.Secondary Outcome
Title Mean Survivin H Score for All Participants
Hide Description Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
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Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.0  (47.25)
18.Secondary Outcome
Title Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants
Hide Description Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.
Time Frame Tumor samples taken at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided enough tumor samples for this evaluation
Arm/Group Title Lapatinib Monotherapy
Hide Arm/Group Description:
Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.9  (26.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib Monotherapy
Hide Arm/Group Description Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
All-Cause Mortality
Lapatinib Monotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib Monotherapy
Affected / at Risk (%)
Total   14/58 (24.14%) 
Cardiac disorders   
Ventricular dysfunction  1  1/58 (1.72%) 
Gastrointestinal disorders   
Nausea  1  1/58 (1.72%) 
Diarrhea  1  1/58 (1.72%) 
Vomiting  1  1/58 (1.72%) 
General disorders   
Malaise  1  1/58 (1.72%) 
Disease progression  1  1/58 (1.72%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  2/58 (3.45%) 
Hepatomegaly  1  1/58 (1.72%) 
Infections and infestations   
Pneumonia  1  2/58 (3.45%) 
Cellulitis  1  1/58 (1.72%) 
Investigations   
Lymphocyte count decreased  1  1/58 (1.72%) 
Blood uric acid increased  1  1/58 (1.72%) 
Metabolism and nutrition disorders   
Anorexia  1  3/58 (5.17%) 
Hypercalcemia  1  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/58 (1.72%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer pain  1  1/58 (1.72%) 
Nervous system disorders   
Dizziness  1  1/58 (1.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lapatinib Monotherapy
Affected / at Risk (%)
Total   58/58 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  4/58 (6.90%) 
Lymph node pain  1  1/58 (1.72%) 
Iron deficiency anemia  1  1/58 (1.72%) 
Leukopenia  1  1/58 (1.72%) 
Cardiac disorders   
Supraventricular extrasystoles  1  1/58 (1.72%) 
Ventricular extrasystoles  1  1/58 (1.72%) 
Ear and labyrinth disorders   
Vertigo  1  1/58 (1.72%) 
Motion sickness  1  1/58 (1.72%) 
Eye disorders   
Abnormal sensation in eye  1  1/58 (1.72%) 
Dry eye  1  1/58 (1.72%) 
Eyelid edema  1  1/58 (1.72%) 
Blepharospasm  1  1/58 (1.72%) 
Scleral hemorrhage  1  1/58 (1.72%) 
Conjunctivitis  1  1/58 (1.72%) 
Conjunctival hyperemia  1  1/58 (1.72%) 
Diplopia  1  1/58 (1.72%) 
Vision blurred  1  1/58 (1.72%) 
Gastrointestinal disorders   
Diarrhea  1  36/58 (62.07%) 
Stomatitis  1  27/58 (46.55%) 
Nausea  1  22/58 (37.93%) 
Vomiting  1  12/58 (20.69%) 
Constipation  1  11/58 (18.97%) 
Abdominal pain upper  1  6/58 (10.34%) 
Abdominal pain  1  4/58 (6.90%) 
Dry mouth  1  3/58 (5.17%) 
Hemorrhoids  1  3/58 (5.17%) 
Gastritis  1  2/58 (3.45%) 
Gastric ulcer  1  2/58 (3.45%) 
Stomach discomfort  1  2/58 (3.45%) 
Dyspepsia  1  2/58 (3.45%) 
Ascites  1  2/58 (3.45%) 
Flatulence  1  1/58 (1.72%) 
Cheilitis  1  1/58 (1.72%) 
Hemorrhoidal hemorrhage  1  1/58 (1.72%) 
Epigastric discomfort  1  1/58 (1.72%) 
Glossitis  1  1/58 (1.72%) 
Abdominal distension  1  1/58 (1.72%) 
Proctalgia  1  1/58 (1.72%) 
Umbilical hernia  1  1/58 (1.72%) 
General disorders   
Fatigue  1  23/58 (39.66%) 
Pyrexia  1  11/58 (18.97%) 
Chest pain  1  5/58 (8.62%) 
Malaise  1  4/58 (6.90%) 
Edema  1  3/58 (5.17%) 
Edema peripheral  1  3/58 (5.17%) 
Pain  1  3/58 (5.17%) 
Chest discomfort  1  1/58 (1.72%) 
Ulcer  1  1/58 (1.72%) 
Asthenia  1  1/58 (1.72%) 
Hepatobiliary disorders   
Hepatic pain  1  1/58 (1.72%) 
Hyperbilirubinemia  1  1/58 (1.72%) 
Immune system disorders   
Seasonal allergy  1  2/58 (3.45%) 
Infections and infestations   
Nasopharyngitis  1  13/58 (22.41%) 
Paronychia  1  4/58 (6.90%) 
Pneumonia  1  1/58 (1.72%) 
Rhinitis  1  3/58 (5.17%) 
Cellulitis  1  2/58 (3.45%) 
Cystitis  1  3/58 (5.17%) 
Pharyngitis  1  2/58 (3.45%) 
Influenza  1  1/58 (1.72%) 
Gastroenteritis  1  1/58 (1.72%) 
Otitis externa  1  1/58 (1.72%) 
Eye lid infection  1  1/58 (1.72%) 
Localized infection  1  1/58 (1.72%) 
Abscess limb  1  1/58 (1.72%) 
Tinea pedis  1  1/58 (1.72%) 
Herpes zoster  1  1/58 (1.72%) 
Urinary tract infection  1  1/58 (1.72%) 
Hordeolum  1  1/58 (1.72%) 
Skin infection  1  1/58 (1.72%) 
Chronic sinusitis  1  1/58 (1.72%) 
Omphalitis  1  1/58 (1.72%) 
Injury, poisoning and procedural complications   
Nail avulsion  1  1/58 (1.72%) 
Thermal burn  1  1/58 (1.72%) 
Skin laceration  1  1/58 (1.72%) 
Brachial plexus injury  1  1/58 (1.72%) 
Hypersensitivity  1  1/58 (1.72%) 
Investigations   
Weight decreased  1  14/58 (24.14%) 
Alanine aminotransferase increased  1  13/58 (22.41%) 
Aspartate aminotransferase increased  1  12/58 (20.69%) 
Blood alkaline phosphatase increased  1  9/58 (15.52%) 
Blood bilirubin increased  1  7/58 (12.07%) 
Hemoglobin decreased  1  4/58 (6.90%) 
Neutrophil count decreased  1  4/58 (6.90%) 
Blood urine present  1  4/58 (6.90%) 
Blood uric acid increased  1  2/58 (3.45%) 
White blood cell count decreased  1  3/58 (5.17%) 
Lymphocyte count decreased  1  1/58 (1.72%) 
Eosinophil count decreased  1  2/58 (3.45%) 
Neutrophil count increased  1  2/58 (3.45%) 
White blood cell count increased  1  2/58 (3.45%) 
Protein urine  1  2/58 (3.45%) 
Blood urea increased  1  2/58 (3.45%) 
Hematocrit decreased  1  1/58 (1.72%) 
Gamma-glutamyltransferase increased  1  1/58 (1.72%) 
Ejection fraction decreased  1  1/58 (1.72%) 
Platelet count decreased  1  1/58 (1.72%) 
Platelet count increased  1  1/58 (1.72%) 
Blood albumin decreased  1  1/58 (1.72%) 
Blood creatinine increased  1  1/58 (1.72%) 
Blood triglycerides increased  1  1/58 (1.72%) 
Blood sodium decreased  1  1/58 (1.72%) 
Blood glucose decreased  1  1/58 (1.72%) 
Blood iron decreased  1  1/58 (1.72%) 
Blood urea decreased  1  1/58 (1.72%) 
Red blood cell count decreased  1  1/58 (1.72%) 
Protein total decreased  1  1/58 (1.72%) 
Weight increased  1  1/58 (1.72%) 
Monocyte count increased  1  1/58 (1.72%) 
Specific gravity urine  1  1/58 (1.72%) 
Metabolism and nutrition disorders   
Anorexia  1  20/58 (34.48%) 
Hypercalcemia  1  1/58 (1.72%) 
Hyperkalemia  1  1/58 (1.72%) 
Hyperglycemia  1  1/58 (1.72%) 
Hyperuricemia  1  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  10/58 (17.24%) 
Shoulder pain  1  3/58 (5.17%) 
Arthralgia  1  2/58 (3.45%) 
Periarthritis  1  1/58 (1.72%) 
Musculoskeletal stiffness  1  1/58 (1.72%) 
Myalgia  1  1/58 (1.72%) 
Muscular weakness  1  1/58 (1.72%) 
Muscle spasms  1  1/58 (1.72%) 
Neck pain  1  1/58 (1.72%) 
Flank pain  1  1/58 (1.72%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer pain  1  4/58 (6.90%) 
Nervous system disorders   
Headache  1  7/58 (12.07%) 
Dysgeusia  1  4/58 (6.90%) 
Dizziness  1  2/58 (3.45%) 
Hypoesthesia  1  2/58 (3.45%) 
Somnolence  1  2/58 (3.45%) 
Hepatic encephalopathy  1  1/58 (1.72%) 
Psychiatric disorders   
Insomnia  1  11/58 (18.97%) 
Mood altered  1  1/58 (1.72%) 
Anxiety disorder  1  1/58 (1.72%) 
Renal and urinary disorders   
Dysuria  1  2/58 (3.45%) 
Pollakiuria  1  2/58 (3.45%) 
Proteinuria  1  1/58 (1.72%) 
Urinary incontinence  1  1/58 (1.72%) 
Urinary retention  1  1/58 (1.72%) 
Cystitis-like symptom  1  1/58 (1.72%) 
Reproductive system and breast disorders   
Genital hemorrhage  1  1/58 (1.72%) 
Breast pain  1  1/58 (1.72%) 
Breast discharge  1  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/58 (15.52%) 
Epistaxis  1  7/58 (12.07%) 
Nasal dryness  1  5/58 (8.62%) 
Dyspnea  1  4/58 (6.90%) 
Productive cough  1  3/58 (5.17%) 
Pharyngolaryngeal pain  1  2/58 (3.45%) 
Upper respiratory tract inflammation  1  2/58 (3.45%) 
Pleural effusion  1  1/58 (1.72%) 
Postnasal drip  1  1/58 (1.72%) 
Dysphonia  1  1/58 (1.72%) 
Rhinorrhea  1  1/58 (1.72%) 
Skin and subcutaneous tissue disorders   
Rash  1  23/58 (39.66%) 
Pruritus  1  13/58 (22.41%) 
Acne  1  12/58 (20.69%) 
Dry skin  1  9/58 (15.52%) 
Palmar-plantar erythrodysesthesia syndrome  1  7/58 (12.07%) 
Exfoliative rash  1  5/58 (8.62%) 
Comedone  1  5/58 (8.62%) 
Seborrhoeic dermatitis  1  4/58 (6.90%) 
Nail disorder  1  4/58 (6.90%) 
Ingrowing nail  1  4/58 (6.90%) 
Eczema  1  2/58 (3.45%) 
Erythema multiforme  1  2/58 (3.45%) 
Skin exfoliation  1  2/58 (3.45%) 
Skin chapped  1  1/58 (1.72%) 
Erythema  1  1/58 (1.72%) 
Rash erythematous  1  1/58 (1.72%) 
Pigmentation disorder  1  1/58 (1.72%) 
Dermatitis contact  1  1/58 (1.72%) 
Generalized erythema  1  1/58 (1.72%) 
Toxic skin eruption  1  1/58 (1.72%) 
Asteatotic eczema  1  1/58 (1.72%) 
Hair disorder  1  1/58 (1.72%) 
Urticaria  1  1/58 (1.72%) 
Decubitus ulcer  1  1/58 (1.72%) 
Vascular disorders   
Flushing  1  4/58 (6.90%) 
Hot flush  1  2/58 (3.45%) 
Vasodilatation  1  1/58 (1.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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: NCT00320411     History of Changes
Other Study ID Numbers: EGF104911
First Submitted: May 1, 2006
First Posted: May 3, 2006
Results First Submitted: November 10, 2009
Results First Posted: December 14, 2009
Last Update Posted: January 31, 2019