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A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00073008
Recruitment Status : Terminated (Based on interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment was stopped due to lack of efficacy)
First Posted : November 17, 2003
Results First Posted : January 6, 2010
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer, Non-Small Cell
Intervention Drug: GW572016 (lapatinib)
Enrollment 131

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description Oral lapatinib 1500 mg once daily (QD) Oral lapatinib 500 mg twice daily (BID)
Period Title: Overall Study
Started 65 66
Completed 3 3
Not Completed 62 63
Reason Not Completed
Missing             6             6
Withdrawal by Subject             2             2
Lost to Follow-up             1             3
Death             46             47
"Other" selected on Case Report Form             7             5
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID Total
Hide Arm/Group Description Oral lapatinib 1500 mg once daily (QD) Oral lapatinib 500 mg twice daily (BID) Total of all reporting groups
Overall Number of Baseline Participants 65 66 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 66 participants 131 participants
65.1  (12.03) 65.2  (10.56) 65.1  (11.27)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Female
33
  50.8%
40
  60.6%
73
  55.7%
Male
32
  49.2%
26
  39.4%
58
  44.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
White 54 56 110
Black 4 1 5
Asian 4 5 9
American Hispanic 2 4 6
Other 1 0 1
Histology at diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Squamous cell 9 3 12
Bronchioloalveolar carcinoma (BAC) 3 2 5
Adenocarcinoma with BAC features 8 13 21
Adenocarcinoma without BAC features 34 43 77
Other non-small cell lung cancer type 5 1 6
Other 4 2 6
Missing 2 2 4
[1]
Measure Description: Type of lung cancer
1.Primary Outcome
Title Tumor Response in the Targeted Population Through the End of Treatment
Hide Description Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.
Time Frame Baseline and then every 8 weeks through end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC)
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 24 32
Measure Type: Number
Unit of Measure: participants
Complete response 0 0
Partial response 0 0
Stable disease 5 9
Progressive disease 18 20
Missing 1 3
2.Secondary Outcome
Title Progression-free Survival (PFS) at Four Months in the Targeted Population
Hide Description Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.
Time Frame From randomization and then every 8 weeks up to four months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Targeted Population
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 24 32
Measure Type: Number
Unit of Measure: percentage of participants
34.5 19.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib 1500 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier estimate
Estimated Value 34.5
Confidence Interval 95%
13.7 to 55.4
Estimation Comments Percentage of surviving participants who were progression free 4 months after the date of randomization
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lapatinib 500 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier estimate
Estimated Value 19.7
Confidence Interval 95%
2.9 to 36.4
Estimation Comments Percentage of surviving participants who were progression free 4 months after the date of randomization
3.Secondary Outcome
Title Progression-free Survival (PFS) at Four Months in the Non-Targeted Population
Hide Description Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.
Time Frame From randomization and then every 8 weeks up to four months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 41 34
Measure Type: Number
Unit of Measure: percentage of participants
27.1 18.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib 1500 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier estimate
Estimated Value 27.1
Confidence Interval 95%
11.9 to 42.3
Estimation Comments Percentage of surviving participants who were progression free 4 months after the date of randomization
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lapatinib 500 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier estimate
Estimated Value 18.3
Confidence Interval 95%
3.9 to 32.6
Estimation Comments Percentage of surviving participants who were progression free 4 months after the date of randomization
4.Secondary Outcome
Title The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue
Hide Description To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed.
Time Frame From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pharmacokinetics (PK) of Lapatinib
Hide Description To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed.
Time Frame From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Pharmacogenetics (PgX)
Hide Description To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed.
Time Frame From randomization at every 4-week assessment through end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Quality of Life
Hide Description Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed.
Time Frame Baseline and then every 4 weeks through end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Time to Response
Hide Description Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed.
Time Frame From randomization and then every 8 weeks to time of response to study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Duration of Response
Hide Description For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed.
Time Frame Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to Tumor Progression
Hide Description Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed.
Time Frame From randomization and then every 8 weeks to disease progression or death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed.
Time Frame From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review
Hide Description Comparison of the specific cell type (histology) of non-small cell lung cancer from participant’s tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed.
Time Frame Anytime from Baseline through end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Tumor Response in the Non-Targeted Population Through the End of Treatment
Hide Description Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision)
Time Frame Baseline and then every 8 weeks through end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Oral lapatinib 1500 mg once daily (QD)
Oral lapatinib 500 mg twice daily (BID)
Overall Number of Participants Analyzed 41 34
Measure Type: Number
Unit of Measure: participants
Complete response 0 0
Partial response 1 0
Stable disease 10 6
Progressive disease 27 25
Missing 3 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description Oral lapatinib 1500 mg once daily (QD) Oral lapatinib 500 mg twice daily (BID)
All-Cause Mortality
Lapatinib 1500 mg QD Lapatinib 500 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib 1500 mg QD Lapatinib 500 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   15/65 (23.08%)   17/66 (25.76%) 
Blood and lymphatic system disorders     
Anemia  1  0/65 (0.00%)  1/66 (1.52%) 
Cardiac disorders     
Pleural effusion  1  2/65 (3.08%)  0/66 (0.00%) 
Atrial fibrillation  1  2/65 (3.08%)  0/66 (0.00%) 
Angina unstable  1  0/65 (0.00%)  1/66 (1.52%) 
Cardiac tamponade  1  1/65 (1.54%)  0/66 (0.00%) 
Pericardial effusion  1  0/65 (0.00%)  1/66 (1.52%) 
Ear and labyrinth disorders     
Vertigo positional  1  0/65 (0.00%)  1/66 (1.52%) 
Gastrointestinal disorders     
Diarrhea  1  3/65 (4.62%)  0/66 (0.00%) 
Nausea  1  1/65 (1.54%)  2/66 (3.03%) 
Vomiting  1  1/65 (1.54%)  2/66 (3.03%) 
Abdominal pain  1  0/65 (0.00%)  1/66 (1.52%) 
Constipation  1  1/65 (1.54%)  0/66 (0.00%) 
Diarrhea hemorrhagic  1  0/65 (0.00%)  1/66 (1.52%) 
Ileus  1  1/65 (1.54%)  0/66 (0.00%) 
General disorders     
Asthenia  1  1/65 (1.54%)  0/66 (0.00%) 
Chest pain  1  0/65 (0.00%)  1/66 (1.52%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/65 (0.00%)  1/66 (1.52%) 
Infections and infestations     
Pneumonia  1  1/65 (1.54%)  1/66 (1.52%) 
Sepsis  1  0/65 (0.00%)  1/66 (1.52%) 
Urinary tract infection  1  1/65 (1.54%)  0/66 (0.00%) 
Injury, poisoning and procedural complications     
Compression fracture  1  1/65 (1.54%)  0/66 (0.00%) 
Hip fracture  1  0/65 (0.00%)  1/66 (1.52%) 
Investigations     
Ejection fraction decreased  1  2/65 (3.08%)  0/66 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/65 (1.54%)  0/66 (0.00%) 
Dehydration  1  1/65 (1.54%)  0/66 (0.00%) 
Fluid overload  1  0/65 (0.00%)  1/66 (1.52%) 
Hyperuricemia  1  1/65 (1.54%)  0/66 (0.00%) 
Hyponatremia  1  0/65 (0.00%)  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/65 (1.54%)  1/66 (1.52%) 
Arthralgia  1  1/65 (1.54%)  0/66 (0.00%) 
Pain in extremity  1  1/65 (1.54%)  0/66 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  0/65 (0.00%)  1/66 (1.52%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/65 (1.54%)  0/66 (0.00%) 
Renal failure  1  0/65 (0.00%)  1/66 (1.52%) 
Renal failure acute  1  0/65 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/65 (1.54%)  5/66 (7.58%) 
Dyspnea  1  1/65 (1.54%)  1/66 (1.52%) 
Hemoptysis  1  0/65 (0.00%)  1/66 (1.52%) 
Hypoxia  1  0/65 (0.00%)  1/66 (1.52%) 
Lung infiltration  1  0/65 (0.00%)  1/66 (1.52%) 
Pulmonary hemorrhage  1  0/65 (0.00%)  1/66 (1.52%) 
Respiratory distress  1  0/65 (0.00%)  1/66 (1.52%) 
Vascular disorders     
Deep vein thrombosis  1  0/65 (0.00%)  1/66 (1.52%) 
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 1500 mg QD Lapatinib 500 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   64/65 (98.46%)   63/66 (95.45%) 
Blood and lymphatic system disorders     
anaemia  1  4/65 (6.15%)  3/66 (4.55%) 
Gastrointestinal disorders     
Diarrhea  1  39/65 (60.00%)  33/66 (50.00%) 
Nausea  1  25/65 (38.46%)  16/66 (24.24%) 
Constipation  1  10/65 (15.38%)  11/66 (16.67%) 
Vomiting  1  15/65 (23.08%)  6/66 (9.09%) 
abdominal pain  1  6/65 (9.23%)  6/66 (9.09%) 
flatulence  1  3/65 (4.62%)  5/66 (7.58%) 
dyspepsia  1  1/65 (1.54%)  5/66 (7.58%) 
stomatitis  1  3/65 (4.62%)  3/66 (4.55%) 
General disorders     
Fatigue  1  24/65 (36.92%)  20/66 (30.30%) 
Pyrexia  1  9/65 (13.85%)  4/66 (6.06%) 
edema peripheral  1  5/65 (7.69%)  5/66 (7.58%) 
chest pain  1  4/65 (6.15%)  5/66 (7.58%) 
asthenia  1  4/65 (6.15%)  4/66 (6.06%) 
chills  1  5/65 (7.69%)  2/66 (3.03%) 
chest discomfort  1  2/65 (3.08%)  4/66 (6.06%) 
Infections and infestations     
nasopharyangitis  1  3/65 (4.62%)  4/66 (6.06%) 
upper respiratory tract infection  1  3/65 (4.62%)  4/66 (6.06%) 
pneumonia  1  2/65 (3.08%)  4/66 (6.06%) 
Investigations     
weight decreased  1  7/65 (10.77%)  2/66 (3.03%) 
Metabolism and nutrition disorders     
Anorexia  1  17/65 (26.15%)  15/66 (22.73%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  9/65 (13.85%)  12/66 (18.18%) 
musculoskeletal chest pain  1  5/65 (7.69%)  5/66 (7.58%) 
pain in extremity  1  4/65 (6.15%)  4/66 (6.06%) 
arthralgia  1  2/65 (3.08%)  4/66 (6.06%) 
Nervous system disorders     
Dysgeusia  1  7/65 (10.77%)  8/66 (12.12%) 
Dizziness  1  6/65 (9.23%)  7/66 (10.61%) 
headache  1  6/65 (9.23%)  3/66 (4.55%) 
neuropathy peripheral  1  4/65 (6.15%)  2/66 (3.03%) 
Psychiatric disorders     
insomnia  1  9/65 (13.85%)  3/66 (4.55%) 
anxiety  1  5/65 (7.69%)  2/66 (3.03%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  11/65 (16.92%)  14/66 (21.21%) 
Cough  1  11/65 (16.92%)  9/66 (13.64%) 
Epistaxis  1  6/65 (9.23%)  8/66 (12.12%) 
haemoptysis  1  3/65 (4.62%)  7/66 (10.61%) 
dysphonia  1  4/65 (6.15%)  3/66 (4.55%) 
pulmonary embolism  1  2/65 (3.08%)  5/66 (7.58%) 
dyspnoea  1  3/65 (4.62%)  3/66 (4.55%) 
Skin and subcutaneous tissue disorders     
Rash  1  31/65 (47.69%)  27/66 (40.91%) 
Dry skin  1  9/65 (13.85%)  10/66 (15.15%) 
pruritus  1  5/65 (7.69%)  7/66 (10.61%) 
alopecia  1  5/65 (7.69%)  3/66 (4.55%) 
dermatitis acneiform  1  4/65 (6.15%)  4/66 (6.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Based on interim analysis and predefined stopping rules for futility, the study was discontinued due to lack of efficacy. At that time, no additional participants were added; enrolled participants could continue on treatment, following the protocol.
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: NCT00073008     History of Changes
Obsolete Identifiers: NCT00084955
Other Study ID Numbers: EGF20014
First Submitted: November 13, 2003
First Posted: November 17, 2003
Results First Submitted: June 15, 2009
Results First Posted: January 6, 2010
Last Update Posted: February 28, 2017