Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281658
Recruitment Status : Active, not recruiting
First Posted : January 25, 2006
Results First Posted : June 1, 2011
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Drug: lapatinib (GW572016) oral tablets
Drug: paclitaxel infusion
Enrollment 443
Recruitment Details  
Pre-assignment Details At the time of disease progression, participants had the option to be unblinded. Participants (pts) who were on placebo+paclitaxel could continue in an open-label lapatinib monotherapy extension phase until further progression or an unacceptable toxicity. All participants were followed for survival. The unblinding was performed by a third party.
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Lapatinib 1500 mg
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks Lapatinib 1500 mg administered once daily
Period Title: Double-blind, Randomized Phase
Started 222 222 [1] 0
Completed 85 [2] 168 [2] 0
Not Completed 137 54 0
Reason Not Completed
Death             120             46             0
Lost to Follow-up             12             5             0
Withdrawal by Subject             4             1             0
Participant Entered New Protocol             1             1             0
Screen Failure; Randomized in Error             0             1             0
[1]
Of these participants, 149 entered the open-label extension phase.
[2]
For the purposes of this report, completed pts are pts ongoing at the time of the analysis.
Period Title: Open-label Monotherapy Extension Phase
Started 0 0 149
Completed 0 0 48 [1]
Not Completed 0 0 101
Reason Not Completed
Death             0             0             97
Lost to Follow-up             0             0             3
Withdrawal by Subject             0             0             1
[1]
For the purposes of this report, completed pts are pts ongoing at the time of the analysis.
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Total
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 222 222 444
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 222 participants 444 participants
49.1  (10.74) 49.3  (9.75) 49.2  (10.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
Female
222
 100.0%
217
  97.7%
439
  98.9%
Male
0
   0.0%
5
   2.3%
5
   1.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
White 9 13 22
Asian 192 192 384
Hispanic 21 16 37
Missing 0 1 1
Number of participants with any visceral metastatic disease and with only non-visceral disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
Visceral 187 186 373
Non-visceral 35 36 71
[1]
Measure Description: Metastasis is defined as the spread of a tumor or cancerous cells from the primary site to one or more sites elsewhere in the body. Visceral metastasis is defined as the spread of cancer to viscera, the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas, or intestines). Non-visceral organs are defined as any organ not considered visceral.
Number of Participants with the Indicated Hormone Receptor Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
ER+ and/or PgR+ or Unknown 111 113 224
ER- and PgR- 111 109 220
[1]
Measure Description: Cancer cells have hormone receptor expression of Estrogen Receptor (ER) and/or Progesterone Receptor (PR) and are thus considered to be ER+ and/or PgR+ cells, respectively.
Number of Participants with the Indicated Stage of Disease at Initial Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
Stage I to II 107 119 226
Stage III 75 68 143
Stage IV 30 24 54
Unknown 10 11 21
[1]
Measure Description: The stage of cancer is a description of the extent to which the cancer has spread. Stage I cancer is localized; Stage II cancer has not started to spread into the surrounding tissue, but the tumor is larger than in Stage I; Stage III cancer is locally advanced and/or involves local lymph nodes; Stage IV cancer has spread to other organs.
Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
0, Fully Active 103 113 216
1, Ambulatory, Restricted Strenuous Activity 119 109 228
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment, and scores indicate: 0, fully active; 1, ambulatory, restricted strenuous activity; 2, ambulatory, no work activity; 3, partially confined to bed; 5, death. Participants were required to have a baseline ECOG performance status of 0 or 1 for study participation.
Number of Participants with the Indicated Number of Metastatic Sites   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
Greater than or equal to 3 131 115 246
Less than 3 91 107 198
[1]
Measure Description: Tumor cells move from the primary site to other sites in the body, where they continue to multiply and eventually form another clinically detectable tumor; thus, the site becomes metastatic.
Number of Participants in the Indicated Age Groups  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 222 participants 444 participants
Greater than or equal to 65 years of age 16 13 29
Less than 65 years of age 206 209 415
Mean Time of Disease-Free Interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 222 participants 222 participants 444 participants
27.51  (27.481) 29.04  (34.522) 28.27  (31.174)
[1]
Measure Description: The disease-free interval was defined as the time from initial diagnosis to metastases.
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame Randomization to death (up to maximum of Month 53)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 222 222
Median (95% Confidence Interval)
Unit of Measure: months
27.8
(23.2 to 32.2)
20.5
(17.9 to 24.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments two-sided p-value
Method Wald Chi-squared
Comments Adjusted for hormonal status, metastatic disease site, initial diagnosis stage, ECOG status, number of metastatic sites, age and disease-free interval
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.49 to 0.82
Estimation Comments Adjusted HR based on Cox Regression model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments two-sided p-value
Method Log Rank
Comments Stratified log-rank test, stratifying for metastatic disease sites and hormonal status
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval 95%
0.58 to 0.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the time from randomization until the earliest date of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase. Disease progression is based on the assessments by the investigator.
Time Frame Randomization to disease progression or death (up to a maximum of Month 53)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 222 222
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(9.2 to 11.1)
6.5
(5.5 to 7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.42 to 0.64
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Response (OR)
Hide Description OR, evaluated per Response Evaluation Criteria in Solid Tumors (RECIST), is defined as the number of participants achieving either a confirmed complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) of tumor, which were based on confirmed responses from the investigator assessment of best OR during the randomized phase. Participants with unknown or missing responses were treated as non-responders.
Time Frame Randomization to disease progression or death (up to a maximum of Month 53)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 222 222
Measure Type: Number
Unit of Measure: participants
154 110
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.30
Confidence Interval 95%
1.54 to 3.47
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clinical Benefit
Hide Description Clinical benefit is defined as the number of participants achieving either a confirmed CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.
Time Frame Randomization to disease progression or death (up to a maximum of Month 53)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 222 222
Measure Type: Number
Unit of Measure: participants
166 124
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.34
Confidence Interval 95%
1.54 to 3.58
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined for the subset of participants with a confirmed CR or PR as the time from first documented evidence of CR or PR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause during the randomized phase. Only participants with a confirmed CR or PR were included in this analysis. Disease progression is based on the assessments by the investigator.
Time Frame Randomization to disease progression or death (up to a maximum of Month 53)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Population with a confirmed CR or PR
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 154 110
Median (95% Confidence Interval)
Unit of Measure: months
9.3
(7.7 to 10.7)
5.8
(5.6 to 7.4)
6.Secondary Outcome
Title Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72
Hide Description The original outcome measure to be analyzed was time to response; however, data are presented as the number of participants with a response at each nominal visit. Responses are based on the investigator’s assessment, and only participants with a confirmed CR or PR were included in this analysis.
Time Frame Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Population with a confirmed CR or PR
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Overall Number of Participants Analyzed 154 110
Measure Type: Number
Unit of Measure: participants
Week 8 94 61
Week 12 40 28
Week 16 6 11
Week 24 7 8
Week 32 3 2
Week 40 0 0
Week 48 1 0
Week 56 1 0
Week 64 1 0
Week 72 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events and adverse events were collected in the Safety Population, comprised of all randomized participants who received at least one dose of investigational product.
 
Arm/Group Title Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Lapatinib 1500 mg
Hide Arm/Group Description Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
All-Cause Mortality
Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/222 (29.73%)   30/221 (13.57%)   7/149 (4.70%) 
Blood and lymphatic system disorders       
Neutropenia  1  36/222 (16.22%)  10/221 (4.52%)  0/149 (0.00%) 
Leukopenia  1  7/222 (3.15%)  1/221 (0.45%)  0/149 (0.00%) 
Febrile neutropenia  1  6/222 (2.70%)  1/221 (0.45%)  0/149 (0.00%) 
Granulocytopenia  1  4/222 (1.80%)  0/221 (0.00%)  0/149 (0.00%) 
Cardiac disorders       
Left ventricular dysfunction  1  3/222 (1.35%)  0/221 (0.00%)  0/149 (0.00%) 
Cardiac failure chronic  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  10/222 (4.50%)  0/221 (0.00%)  1/149 (0.67%) 
Vomiting  1  1/222 (0.45%)  1/221 (0.45%)  0/149 (0.00%) 
Adominal pain  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Pancreatitis acute  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Stomatitis  1  0/222 (0.00%)  0/221 (0.00%)  1/149 (0.67%) 
General disorders       
Pyrexia  1  3/222 (1.35%)  0/221 (0.00%)  1/149 (0.67%) 
Fatigue  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Microlithiasis  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Multi-organ failure  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Non-cardiac chest pain  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Hepatic function abnormal  1  0/222 (0.00%)  1/221 (0.45%)  1/149 (0.67%) 
Hepatobiliary disease  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Hepatotoxicity  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  0/222 (0.00%)  0/221 (0.00%)  1/149 (0.67%) 
Infections and infestations       
Cellulitis  1  2/222 (0.90%)  0/221 (0.00%)  0/149 (0.00%) 
Escherichia bacteraemia  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Lung infection  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Pharyngitis  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Pneumonia  1  0/222 (0.00%)  1/221 (0.45%)  1/149 (0.67%) 
Pyelonephritis acute  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Septic shock  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Urinary tract infection  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Viral infection  1  0/222 (0.00%)  1/221 (0.45%)  1/149 (0.67%) 
Injury, poisoning and procedural complications       
Femur fracture  1  0/222 (0.00%)  2/221 (0.90%)  0/149 (0.00%) 
Investigations       
Ejection fraction decreased  1  13/222 (5.86%)  3/221 (1.36%)  0/149 (0.00%) 
Haemoglobin decreased  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Neutrophil count decreased  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  1/222 (0.45%)  1/221 (0.45%)  0/149 (0.00%) 
Hyperglycaemia  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Nervous system disorders       
Intracranial pressure increased  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Presyncope  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Psychiatric disorders       
Completed suicide  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/222 (0.45%)  2/221 (0.90%)  0/149 (0.00%) 
Interstitial lung disease  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Laryngeal oedema  1  1/222 (0.45%)  0/221 (0.00%)  0/149 (0.00%) 
Pleural effusion  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
Pulmonary embolism  1  0/222 (0.00%)  0/221 (0.00%)  1/149 (0.67%) 
Respiratory failure  1  0/222 (0.00%)  0/221 (0.00%)  1/149 (0.67%) 
Vascular disorders       
Deep vein thrombosis  1  0/222 (0.00%)  1/221 (0.45%)  0/149 (0.00%) 
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%
Lapatinib Plus Paclitaxel Placebo Plus Paclitaxel Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   219/222 (98.65%)   206/221 (93.21%)   132/149 (88.59%) 
Blood and lymphatic system disorders       
Neutropenia  1  168/222 (75.68%)  103/221 (46.61%)  8/149 (5.37%) 
Leukopenia  1  113/222 (50.90%)  74/221 (33.48%)  10/149 (6.71%) 
Anemia  1  50/222 (22.52%)  22/221 (9.95%)  0/149 (0.00%) 
Granulocytopenia  1  17/222 (7.66%)  15/221 (6.79%)  0/149 (0.00%) 
Gastrointestinal disorders       
Diarrhea  1  171/222 (77.03%)  64/221 (28.96%)  40/149 (26.85%) 
Nausea  1  66/222 (29.73%)  41/221 (18.55%)  0/149 (0.00%) 
Vomiting  1  48/222 (21.62%)  26/221 (11.76%)  0/149 (0.00%) 
Abdominal pain  1  17/222 (7.66%)  10/221 (4.52%)  0/149 (0.00%) 
Constipation  1  8/222 (3.60%)  18/221 (8.14%)  0/149 (0.00%) 
Dyspepsia  1  11/222 (4.95%)  8/221 (3.62%)  0/149 (0.00%) 
Mouth ulceration  1  16/222 (7.21%)  0/221 (0.00%)  0/149 (0.00%) 
Abdominal pain upper  1  13/222 (5.86%)  2/221 (0.90%)  0/149 (0.00%) 
Abdominal distension  1  12/222 (5.41%)  3/221 (1.36%)  0/149 (0.00%) 
General disorders       
Fatigue  1  47/222 (21.17%)  35/221 (15.84%)  0/149 (0.00%) 
Pyrexia  1  29/222 (13.06%)  30/221 (13.57%)  0/149 (0.00%) 
Oedema  1  8/222 (3.60%)  16/221 (7.24%)  8/149 (5.37%) 
Asthenia  1  15/222 (6.76%)  6/221 (2.71%)  0/149 (0.00%) 
Mucosal inflammation  1  18/222 (8.11%)  3/221 (1.36%)  0/149 (0.00%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  17/222 (7.66%)  9/221 (4.07%)  0/149 (0.00%) 
Hyperbilirubinemia  1  12/222 (5.41%)  2/221 (0.90%)  0/149 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  1  20/222 (9.01%)  12/221 (5.43%)  0/149 (0.00%) 
Nasopharyngitis  1  11/222 (4.95%)  11/221 (4.98%)  0/149 (0.00%) 
Pharyngitis  1  9/222 (4.05%)  11/221 (4.98%)  0/149 (0.00%) 
Paronychia  1  17/222 (7.66%)  1/221 (0.45%)  0/149 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  24/222 (10.81%)  17/221 (7.69%)  9/149 (6.04%) 
Aspartate aminotransferase increased  1  19/222 (8.56%)  16/221 (7.24%)  8/149 (5.37%) 
Hemoglobin decreased  1  22/222 (9.91%)  4/221 (1.81%)  0/149 (0.00%) 
Blood alkaline phosphatase increased  1  11/222 (4.95%)  10/221 (4.52%)  0/149 (0.00%) 
White blood cell decreased  1  10/222 (4.50%)  10/221 (4.52%)  0/149 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite  1  70/222 (31.53%)  41/221 (18.55%)  0/149 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  30/222 (13.51%)  23/221 (10.41%)  0/149 (0.00%) 
Arthralgia  1  18/222 (8.11%)  14/221 (6.33%)  0/149 (0.00%) 
Musculoskeletal pain  1  10/222 (4.50%)  6/221 (2.71%)  0/149 (0.00%) 
Nervous system disorders       
Neuropathy peripheral  1  30/222 (13.51%)  30/221 (13.57%)  15/149 (10.07%) 
Hypoaesthesia  1  18/222 (8.11%)  25/221 (11.31%)  16/149 (10.74%) 
Headache  1  20/222 (9.01%)  20/221 (9.05%)  0/149 (0.00%) 
Dizziness  1  19/222 (8.56%)  10/221 (4.52%)  0/149 (0.00%) 
Peripheral sensory neuropathy  1  12/222 (5.41%)  12/221 (5.43%)  0/149 (0.00%) 
Psychiatric disorders       
Insomnia  1  12/222 (5.41%)  17/221 (7.69%)  0/149 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  22/222 (9.91%)  19/221 (8.60%)  0/149 (0.00%) 
Dyspnea  1  13/222 (5.86%)  12/221 (5.43%)  0/149 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  102/222 (45.95%)  113/221 (51.13%)  61/149 (40.94%) 
Rash  1  130/222 (58.56%)  52/221 (23.53%)  58/149 (38.93%) 
Nail disorder  1  25/222 (11.26%)  3/221 (1.36%)  10/149 (6.71%) 
Pruritus  1  21/222 (9.46%)  6/221 (2.71%)  8/149 (5.37%) 
Dry skin  1  15/222 (6.76%)  3/221 (1.36%)  0/149 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Some participants (PAR) are captured as withdrawing from the study due to death. Per protocol, PAR who died were considered to be study completers and did not withdraw from the study; for the purposes of this report, they are classified as withdrawn.
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00281658     History of Changes
Other Study ID Numbers: EGF104535
First Submitted: January 23, 2006
First Posted: January 25, 2006
Results First Submitted: May 5, 2011
Results First Posted: June 1, 2011
Last Update Posted: September 10, 2019