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Trial record 20 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC

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ClinicalTrials.gov Identifier: NCT01138046
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : September 19, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Intervention Drug: Lapatinib in combination with weekly paclitaxel
Enrollment 12
Recruitment Details  
Pre-assignment Details Six participants who met the eligibility criteria were enrolled into Phase I of the study. These 6 participants continued treatment into Phase II of the study, into which an additional 6 participants were enrolled. A total of 12 participants were followed until death or withdrawal from the study.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Period Title: Overall Study
Started 12
Completed 6
Not Completed 6
Reason Not Completed
Withdrawal due to death             6
Arm/Group Title Lapatinib 1500mg + Paclitaxel 80mg/m^2
Hide Arm/Group Description Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
58.1  (7.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 12 participants
12
1.Primary Outcome
Title Number of Participants With Intolerable Toxicities in Phase I of the Study
Hide Description Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
1
2.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.
Time Frame From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: all participants who received at least one dose of study medication
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: Months
35.6 [1] 
(23.9 to NA)
[1]
Due to an insufficient number of events the upper limit of the 95% confidence Interval could not be calculated.
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.
Time Frame From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: Months
13.9
(7.6 to 27.9)
4.Secondary Outcome
Title Time to Response
Hide Description Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.
Time Frame From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with a CR or a PR were assessed.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
1.9
(1.8 to 1.9)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.
Time Frame From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
14.5
(9.1 to 26.3)
6.Secondary Outcome
Title Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.
Time Frame From the start of treatment until progressive disease/death (up to 1009 Days).
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. All participants who received at least one dose of study medication.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
CR 0
PR 10
SD 1
PD 1
Not evaluable 0
Unkown 0
7.Secondary Outcome
Title Number of Participants With Clinical Benefit Response (CBR)
Hide Description CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for >=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable
Time Frame From the start of treatment until progressive disease/death (up to 1009 Days).
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. All participants who received at least one dose of study medication.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
Complete response 0
Partial response 10
Stable disease >=24 weeks 0
Stable disease <=24 weeks 1
Progressive disease 1
Not evaluable 0
Unknown 0
8.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel
Hide Description Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: Nanogram per milliliter ng/mL
Lapatinib 1500 mg, Day 14
5945.022
(3077.881 to 11482.989)
Lapatinib 1500 mg +Paclitaxel 80 mg/m^2, Day 8
9470.401
(7157.899 to 12530.003)
Paclitaxel 80 mg/m^2, Day 1
3485.229
(2693.037 to 4510.455)
Paclitaxel 80 mg/m2+ Lapatinib 1500 mg, Day 8
3412.332
(2753.083 to 4229.443)
9.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel
Hide Description AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours * nanograms/milliliter (hr*ng/mL)
Lapatinib 1500 mg, Day 14
79518.047
(34664.607 to 182408.525)
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2, Day 8
113078.292
(74630.131 to 171334.285)
Paclitaxel 80 mg/m^2, Day 1
4657.218
(3942.630 to 5501.322)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
5786.123
(4667.500 to 7172.837)
10.Secondary Outcome
Title AUC From Time Zero to Infinity (0-INF) of Paclitaxel
Hide Description AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*ng/mL
Paclitaxel 80 mg/m^2, Day 1
5125.908
(4371.289 to 6010.798)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
6279.964
(5005.596 to 7878.773)
11.Secondary Outcome
Title Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel
Hide Description Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Hr
Lapatinib 1500 mg, Day 14
4.992
(1.50 to 6.08)
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2, Day 8
4.975
(1.95 to 6.00)
Paclitaxel 80 mg/m^2, Day 1
0.992
(0.95 to 1.08)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
0.975
(0.50 to 1.02)
12.Secondary Outcome
Title Distribution Volume at Steady State (Vss) of Paclitaxel
Hide Description Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliliter per meters squared (mL/m^2)
Paclitaxel 80 mg/m^2, Day 1
98909.326
(73404.017 to 133276.831)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
77460.104
(63942.340 to 93835.598)
13.Secondary Outcome
Title Half-life (t1/2) of Paclitaxel
Hide Description Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hr
Paclitaxel 80 mg/m^2, Day 1
12.186
(10.055 to 14.768)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
9.855
(8.477 to 11.457)
14.Secondary Outcome
Title Drug Clearance (CL) of Paclitaxel
Hide Description CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Time Frame Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who provided blood samples for PK evaluation.
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/hour/m^2
Paclitaxel 80 mg/m^2, Day 1
15606.990
(13309.380 to 18301.238)
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
12738.926
(10153.865 to 15982.114)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
 
Arm/Group Title Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Hide Arm/Group Description Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
All-Cause Mortality
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Affected / at Risk (%)
Total   3/12 (25.00%) 
Cardiac disorders   
Left ventricular dysfunction  1  1/12 (8.33%) 
Infections and infestations   
Pneumonia  1  1/12 (8.33%) 
Investigations   
Neutrophil count decreased  1  2/12 (16.67%) 
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 0%
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Affected / at Risk (%)
Total   12/12 (100.00%) 
Blood and lymphatic system disorders   
Leukopenia  1  8/12 (66.67%) 
Neutropenia  1  8/12 (66.67%) 
Lymphopenia  1  6/12 (50.00%) 
Erythropenia  1  3/12 (25.00%) 
Cardiac disorders   
Cardiomegaly  1  1/12 (8.33%) 
Left ventricular dysfunction  1  1/12 (8.33%) 
Ear and labyrinth disorders   
Meniere's disease  1  1/12 (8.33%) 
Eye disorders   
Blepharitis  1  1/12 (8.33%) 
Cataract  1  1/12 (8.33%) 
Erythema of eyelid  1  1/12 (8.33%) 
Eyelid oedema  1  1/12 (8.33%) 
Vision blurred  1  1/12 (8.33%) 
Gastrointestinal disorders   
Diarrhoea  1  11/12 (91.67%) 
Stomatitis  1  8/12 (66.67%) 
Vomiting  1  6/12 (50.00%) 
Nausea  1  5/12 (41.67%) 
Abdominal pain upper  1  3/12 (25.00%) 
Constipation  1  3/12 (25.00%) 
Cheilitis  1  2/12 (16.67%) 
Dental caries  1  2/12 (16.67%) 
Haemorrhoids  1  2/12 (16.67%) 
Abdominal distension  1  1/12 (8.33%) 
Abdominal pain  1  1/12 (8.33%) 
Gastritis  1  1/12 (8.33%) 
Glossitis  1  1/12 (8.33%) 
Periproctitis  1  1/12 (8.33%) 
Proctalgia  1  1/12 (8.33%) 
Toothache  1  1/12 (8.33%) 
General disorders   
Fatigue  1  8/12 (66.67%) 
Oedema  1  3/12 (25.00%) 
Oedema peripheral  1  3/12 (25.00%) 
Pyrexia  1  3/12 (25.00%) 
Mucosal inflammation  1  2/12 (16.67%) 
Discomfort  1  1/12 (8.33%) 
Feeling drunk  1  1/12 (8.33%) 
Feeling hot  1  1/12 (8.33%) 
Injection site reaction  1  1/12 (8.33%) 
Malaise  1  1/12 (8.33%) 
Infections and infestations   
Paronychia  1  7/12 (58.33%) 
Nasopharyngitis  1  6/12 (50.00%) 
Gingivitis  1  2/12 (16.67%) 
Bronchitis  1  1/12 (8.33%) 
Cystitis  1  1/12 (8.33%) 
Erysipelas  1  1/12 (8.33%) 
Folliculitis  1  1/12 (8.33%) 
Influenza  1  1/12 (8.33%) 
Nail infection  1  1/12 (8.33%) 
Subcutaneous abscess  1  1/12 (8.33%) 
Injury, poisoning and procedural complications   
Contusion  1  1/12 (8.33%) 
Fractured coccyx  1  1/12 (8.33%) 
Infusion related reaction  1  1/12 (8.33%) 
Investigations   
Haemoglobin decreased  1  10/12 (83.33%) 
Alanine aminotransferase increased  1  7/12 (58.33%) 
Aspartate aminotransferase increased  1  6/12 (50.00%) 
Haematocrit decreased  1  6/12 (50.00%) 
Blood alkaline phosphatase increased  1  5/12 (41.67%) 
Weight decreased  1  4/12 (33.33%) 
Blood albumin decreased  1  3/12 (25.00%) 
Neutrophil count decreased  1  3/12 (25.00%) 
White blood cell count decreased  1  3/12 (25.00%) 
Basophil count decreased  1  2/12 (16.67%) 
Blood bilirubin increased  1  2/12 (16.67%) 
Monocyte count decreased  1  2/12 (16.67%) 
Platelet count increased  1  2/12 (16.67%) 
Red blood cell count decreased  1  2/12 (16.67%) 
Blood glucose increased  1  1/12 (8.33%) 
Blood potassium decreased  1  1/12 (8.33%) 
Blood potassium increased  1  1/12 (8.33%) 
Blood urea increased  1  1/12 (8.33%) 
Electrocardiogram QT prolonged  1  1/12 (8.33%) 
Eosinophil count decreased  1  1/12 (8.33%) 
Neutrophil count increased  1  1/12 (8.33%) 
White blood cell count increased  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  7/12 (58.33%) 
Dehydration  1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/12 (25.00%) 
Myalgia  1  3/12 (25.00%) 
Back pain  1  2/12 (16.67%) 
Muscular weakness  1  1/12 (8.33%) 
Musculoskeletal pain  1  1/12 (8.33%) 
Musculoskeletal stiffness  1  1/12 (8.33%) 
Osteoarthritis  1  1/12 (8.33%) 
Pain in extremity  1  1/12 (8.33%) 
Periarthritis  1  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  1/12 (8.33%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  8/12 (66.67%) 
Dysgeusia  1  5/12 (41.67%) 
Headache  1  2/12 (16.67%) 
Hypoaesthesia  1  1/12 (8.33%) 
Neuropathy peripheral  1  1/12 (8.33%) 
Somnolence  1  1/12 (8.33%) 
Psychiatric disorders   
Insomnia  1  1/12 (8.33%) 
Renal and urinary disorders   
Neurogenic bladder  1  1/12 (8.33%) 
Reproductive system and breast disorders   
Vaginal discharge  1  1/12 (8.33%) 
Vaginal inflammation  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  5/12 (41.67%) 
Cough  1  3/12 (25.00%) 
Pneumonitis  1  2/12 (16.67%) 
Oropharyngeal discomfort  1  1/12 (8.33%) 
Pharyngeal inflammation  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  12/12 (100.00%) 
Rash  1  8/12 (66.67%) 
Nail disorder  1  6/12 (50.00%) 
Dry skin  1  2/12 (16.67%) 
Erythema  1  2/12 (16.67%) 
Skin hyperpigmentation  1  2/12 (16.67%) 
Acne  1  1/12 (8.33%) 
Dermatitis  1  1/12 (8.33%) 
Dermatitis acneiform  1  1/12 (8.33%) 
Keratolysis exfoliativa acquired  1  1/12 (8.33%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/12 (8.33%) 
Pigmentation disorder  1  1/12 (8.33%) 
Skin fissures  1  1/12 (8.33%) 
Vascular disorders   
Hot flush  1  1/12 (8.33%) 
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: NCT01138046     History of Changes
Other Study ID Numbers: 113806
First Submitted: March 18, 2010
First Posted: June 7, 2010
Results First Submitted: September 15, 2014
Results First Posted: September 19, 2014
Last Update Posted: October 7, 2014