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Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

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: NCT00089999
Recruitment Status : Completed
First Posted : August 23, 2004
Results First Posted : August 29, 2014
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Intervention Drug: Lapatinib
Enrollment 138
Recruitment Details Participants (par.) with histologically confirmed invasive breast cancer with incurable stage IIIb, stage IIIc with T4 lesion, or stage IV disease at primary diagnosis or at relapse after curative-intent surgery and whose tumors overexpressed ErbB2 protein, documented by FISH were eligible for inclusion in this phase II study.
Pre-assignment Details  
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated. Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Period Title: Overall Study
Started 69 69
Completed 0 0
Not Completed 69 69
Reason Not Completed
Adverse Event             4             7
Withdrawal by Subject             0             4
Lost to Follow-up             2             1
Radiological Progression of Cancer             52             44
Symptomatic Progression of Cancer             2             5
Death             3             3
Poor General Condition             1             0
Clinical Progression             1             2
Physician Decision             2             2
Patient Underwent Surgery             2             0
Skin Nodule Over Right Mastectomy             0             1
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID Total
Hide Arm/Group Description Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated. Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated. Total of all reporting groups
Overall Number of Baseline Participants 69 69 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 69 participants 138 participants
53.2  (14.27) 53.4  (13.66) 53.3  (13.92)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
Female
69
 100.0%
69
 100.0%
138
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
White 2 1 3
Black 0 1 1
Asian 36 35 71
American Hispanic 31 32 63
1.Primary Outcome
Title Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)
Hide Description OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. 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 diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.
Time Frame From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of investigational product.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: Participants
CR 0 0
PR 15 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib 1500 mg QD, Lapatinib 500 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.3 to 1.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator
Hide Description OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. 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 diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.
Time Frame From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: Participants
CR 1 2
PR 16 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib 1500 mg QD, Lapatinib 500 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.3 to 1.6
Estimation Comments Overall Response (i.e. sum of Complete and Partial Responses) comparison
3.Secondary Outcome
Title Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator
Hide Description Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (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 a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.
Time Frame From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: Percentage of Participants
IRC 29.0 33.3
Investigator 29.0 40.6
4.Secondary Outcome
Title Time to Response, as Assessed by the IRC and Investigator
Hide Description Time to response is defined as the time from randomization until the first documented evidence of a PR or 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, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. 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 longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Time Frame From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Median (Full Range)
Unit of Measure: Weeks
IRC, n=15, 18
7.9
(7 to 12)
7.9
(7 to 20)
Investigator, n=17, 22
8.0
(7 to 19)
8.0
(5 to 46)
5.Secondary Outcome
Title Duration of Response (DoR), as Assessed by the IRC and Investigator
Hide Description DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.
Time Frame From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Median (Inter-Quartile Range)
Unit of Measure: Weeks
IRC,n=15, 18
27.6
(20.1 to 39.4)
29.0 [1] 
(20.3 to NA)
Investigator, n=17, 22
27.6
(15.4 to 39.4)
29.0
(15.7 to 36.1)
[1]
The upper limit of the 95% confidence interval could not be determined (not reached) because there were not enough events to be able to calculate it.
6.Secondary Outcome
Title Progression-free Survival, as Assessed by the IRC and Investigator
Hide Description Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.
Time Frame From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Median (95% Confidence Interval)
Unit of Measure: Weeks
IRC
19.6
(16.4 to 28.1)
24.4
(19.7 to 35.9)
Investigator
17.6
(12.1 to 20.0)
20.3
(13.3 to 24.4)
7.Secondary Outcome
Title Time to Treatment Failure, as Assessed by IRC and Investigator
Hide Description Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.
Time Frame From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Median (95% Confidence Interval)
Unit of Measure: Weeks
IRC
15.7
(11.6 to 19.3)
17.0
(13.1 to 20.3)
Investigator
12.3
(10.0 to 19.6)
16.1
(12.3 to 23.1)
8.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Hide Description An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.
Time Frame From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of investigational product.
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description:
Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: Participants
Any AE 65 61
Any SAE 15 18
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to 30 days after the last dose (up to Study Week 192).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
 
Arm/Group Title Lapatinib 1500 mg QD Lapatinib 500 mg BID
Hide Arm/Group Description Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated. Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
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   15/69 (21.74%)   18/69 (26.09%) 
Blood and lymphatic system disorders     
Anaemia  1  0/69 (0.00%)  1/69 (1.45%) 
Febrile neutropenia  1  1/69 (1.45%)  0/69 (0.00%) 
Thrombocytopenia  1  0/69 (0.00%)  1/69 (1.45%) 
Cardiac disorders     
Left ventricular dysfunction  1  0/69 (0.00%)  1/69 (1.45%) 
Pericardial effusion  1  1/69 (1.45%)  0/69 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/69 (1.45%)  1/69 (1.45%) 
Constipation  1  0/69 (0.00%)  1/69 (1.45%) 
Gastritis  1  1/69 (1.45%)  0/69 (0.00%) 
Oesophagitis  1  1/69 (1.45%)  0/69 (0.00%) 
Vomiting  1  1/69 (1.45%)  0/69 (0.00%) 
General disorders     
Asthenia  1  0/69 (0.00%)  2/69 (2.90%) 
Pyrexia  1  0/69 (0.00%)  1/69 (1.45%) 
Hepatobiliary disorders     
Hepatic failure  1  0/69 (0.00%)  1/69 (1.45%) 
Hepatic function abnormal  1  1/69 (1.45%)  0/69 (0.00%) 
Hepatorenal syndrome  1  0/69 (0.00%)  1/69 (1.45%) 
Infections and infestations     
Pneumonia  1  2/69 (2.90%)  1/69 (1.45%) 
Urinary tract infection  1  0/69 (0.00%)  3/69 (4.35%) 
Cellulitis  1  1/69 (1.45%)  1/69 (1.45%) 
Peritonitis bacterial  1  0/69 (0.00%)  1/69 (1.45%) 
Injury, poisoning and procedural complications     
Injury  1  1/69 (1.45%)  0/69 (0.00%) 
Multiple injuries  1  0/69 (0.00%)  1/69 (1.45%) 
Investigations     
Ejection fraction decreased  1  2/69 (2.90%)  2/69 (2.90%) 
Metabolism and nutrition disorders     
Dehydration  1  1/69 (1.45%)  0/69 (0.00%) 
Hypercalcaemia  1  0/69 (0.00%)  1/69 (1.45%) 
Hyperuricaemia  1  1/69 (1.45%)  0/69 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/69 (0.00%)  2/69 (2.90%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial cancer  1  0/69 (0.00%)  1/69 (1.45%) 
Nervous system disorders     
Convulsion  1  0/69 (0.00%)  1/69 (1.45%) 
Facial palsy  1  1/69 (1.45%)  0/69 (0.00%) 
Headache  1  1/69 (1.45%)  0/69 (0.00%) 
Intracranial pressure increased  1  0/69 (0.00%)  1/69 (1.45%) 
Loss of consciousness  1  0/69 (0.00%)  1/69 (1.45%) 
Psychiatric disorders     
Confusional state  1  0/69 (0.00%)  1/69 (1.45%) 
Depressed mood  1  1/69 (1.45%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/69 (0.00%)  2/69 (2.90%) 
Dyspnoea  1  0/69 (0.00%)  1/69 (1.45%) 
Respiratory failure  1  1/69 (1.45%)  0/69 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/69 (0.00%)  1/69 (1.45%) 
Vascular disorders     
Thrombophlebitis  1  1/69 (1.45%)  0/69 (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 1500 mg QD Lapatinib 500 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   58/69 (84.06%)   53/69 (76.81%) 
Blood and lymphatic system disorders     
Anaemia  1  3/69 (4.35%)  4/69 (5.80%) 
Gastrointestinal disorders     
Diarrhoea  1  30/69 (43.48%)  34/69 (49.28%) 
Nausea  1  10/69 (14.49%)  9/69 (13.04%) 
Vomiting  1  11/69 (15.94%)  8/69 (11.59%) 
Dyspepsia  1  7/69 (10.14%)  4/69 (5.80%) 
Abdominal pain  1  4/69 (5.80%)  5/69 (7.25%) 
Stomatitis  1  4/69 (5.80%)  1/69 (1.45%) 
General disorders     
Asthenia  1  6/69 (8.70%)  10/69 (14.49%) 
Pyrexia  1  5/69 (7.25%)  4/69 (5.80%) 
Infections and infestations     
Influenza  1  6/69 (8.70%)  6/69 (8.70%) 
Investigations     
Alanine aminotransferase increased  1  5/69 (7.25%)  6/69 (8.70%) 
Blood alkaline phosphatase increased  1  3/69 (4.35%)  7/69 (10.14%) 
Aspartate aminotransferase increased  1  3/69 (4.35%)  6/69 (8.70%) 
Metabolism and nutrition disorders     
Anorexia  1  4/69 (5.80%)  4/69 (5.80%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  11/69 (15.94%)  9/69 (13.04%) 
Pain in extremity  1  5/69 (7.25%)  7/69 (10.14%) 
Arthralgia  1  4/69 (5.80%)  2/69 (2.90%) 
Musculoskeletal chest pain  1  2/69 (2.90%)  4/69 (5.80%) 
Nervous system disorders     
Headache  1  9/69 (13.04%)  8/69 (11.59%) 
Dizziness  1  3/69 (4.35%)  7/69 (10.14%) 
Renal and urinary disorders     
Dry skin  1  3/69 (4.35%)  7/69 (10.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/69 (11.59%)  10/69 (14.49%) 
Dyspnoea  1  1/69 (1.45%)  7/69 (10.14%) 
Pharyngolaryngeal pain  1  3/69 (4.35%)  5/69 (7.25%) 
Skin and subcutaneous tissue disorders     
Rash  1  23/69 (33.33%)  22/69 (31.88%) 
Pruritus  1  15/69 (21.74%)  18/69 (26.09%) 
Alopecia  1  2/69 (2.90%)  5/69 (7.25%) 
Dermatitis acneiform  1  4/69 (5.80%)  0/69 (0.00%) 
Skin exfoliation  1  0/69 (0.00%)  4/69 (5.80%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00089999     History of Changes
Other Study ID Numbers: EGF20009
First Submitted: August 18, 2004
First Posted: August 23, 2004
Results First Submitted: August 18, 2014
Results First Posted: August 29, 2014
Last Update Posted: February 28, 2017