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Trial record 45 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

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: NCT00526669
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : October 1, 2012
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Gastrointestinal Tract
Intervention Drug: Lapatinib and Capecitabine
Enrollment 68
Recruitment Details 68 participants were enrolled in the study, as reflected by the enrollment number in the protocol record; however, one participant elected to not receive study treatment and was thus not included in the Intent-to-Treat Population.
Pre-assignment Details After an initial tumor biopsy (biop.), participants (par.) received lapatinib monotherapy in a 7-day Run-in Period, followed by a second biop. After the second biop., par. received a 14-day course of capecitabine in combination with lapatinib, which continued in the absence of treatment-related toxicity, until disease progression or withdrawal.
Arm/Group Title Lapatinib Lapatinib + Capecitabine
Hide Arm/Group Description Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Period Title: 7-Day Run-in Monotherapy Treatment Phase
Started 67 0
Completed 67 0
Not Completed 0 0
Period Title: Combined Treatment Phase
Started 0 67
Completed 0 59
Not Completed 0 8
Reason Not Completed
Lost to Follow-up             0             2
Withdrawal by Subject             0             2
Sponsor Terminated Study             0             2
Death             0             2
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants
61.4  (12.57)
[1]
Measure Description: Baseline data were collected in members of the Intent-to-Treat Population, comprised of all participants who entered the study and received at least one dose of lapatinib.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
17
  25.4%
Male
50
  74.6%
[1]
Measure Description: Baseline data were collected in members of the Intent-to-Treat Population, comprised of all participants who entered the study and received at least one dose of lapatinib.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
White - White/Caucasian/European Heritage 34
Asian - East Asian Heritage 30
American Indian or Alaskan Native 2
Asian - South East Asian Heritage 1
[1]
Measure Description: Baseline data were collected in members of the Intent-to-Treat Population, comprised of all participants who entered the study and received at least one dose of lapatinib.
1.Primary Outcome
Title Change From Start of Run-in Period in Biomarker Expression Levels at Day 0
Hide Description Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.
Time Frame evaluated at baseline and after 7 days of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.
Arm/Group Title Lapatinib
Hide Arm/Group Description:
Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
Overall Number of Participants Analyzed 67
Median (Full Range)
Unit of Measure: ratio
Thymidylate synthase (TS), n=34
0.38
(-2.33 to 7.25)
Deoxypyridinoline (DPD), n=26
0.12
(-0.61 to 1.04)
EGFR/HER1, n=32
0.15
(-1.88 to 41.89)
HER2, n=28
0.01
(-0.29 to 1.61)
HER3, n=33
0.87
(-36.31 to 8.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments Biomarker: TS
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lapatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments Biomarker: DPD
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lapatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments Biomarker: EGFR/HER1
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lapatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Biomarker: HER2
Method Wilcoxon signed rank test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lapatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments Biomarker: HER3
Method Wilcoxon signed rank test
Comments [Not Specified]
2.Primary Outcome
Title Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])
Hide Description Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.
Time Frame From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
17.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 17.9
Confidence Interval (2-Sided) 95%
9.6 to 29.2
Estimation Comments The estimated value represents the percentage of participants with complete response or partial response.
3.Primary Outcome
Title Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)
Hide Description 5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.
Time Frame From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 29
Confidence Interval (2-Sided) 95%
17.9 to 40.3
Estimation Comments The estimated value reflects the percentage of participants who achieved progression-free survival.
4.Secondary Outcome
Title PFS
Hide Description PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).
Time Frame From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Median (95% Confidence Interval)
Unit of Measure: weeks
14.3
(12.6 to 18.7)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.
Time Frame From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Median (95% Confidence Interval)
Unit of Measure: weeks
27.6
(21.7 to 39.4)
6.Secondary Outcome
Title Time to Progression (All Deaths Are Treated as Competing Risk)
Hide Description Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.
Time Frame From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: weeks
18.9
(7.7 to 56.7)
7.Secondary Outcome
Title Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)
Hide Description Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.
Time Frame From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: weeks
14.3
(7.4 to 24.9)
8.Secondary Outcome
Title Time to Response
Hide Description Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.
Time Frame Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: weeks
NA [1] 
(NA to NA)
[1]
Insufficient numbers of responses were observed; therefore, the median and the inter-quartile range cannot be estimated.
9.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.
Time Frame From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: weeks
18.4
(12.3 to 36.0)
10.Secondary Outcome
Title Number of Participants in the Indicated Categories for Best Overall Response (BOR)
Hide Description Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as 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 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.
Time Frame From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
CR 0
PR 12
SD 31
PD 16
Unknown 8
11.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points
Hide Description Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 10
Week 2, AGI; n=57 9
Week 3, AGI; n=61 10
Week 6, AGI; n=47 4
Week 9, AGI; n=41 2
Week 12, AGI; n=31 4
Week 15, AGI; n=22 3
Week 18, AGI; n=17 1
Week 21, AGI; n=14 1
Week 24, AGI; n=11 1
Week 30, AGI; n=9 0
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 1
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
Withdrawal /study conclusion, AGI; n=50 11
Worst-case on-therapy, AGI; n=65 29
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=50 0
Worst-case on-therapy, ItoG3; n=65 0
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=50 0
Worst-case on-therapy ItoG4; n=65 0
12.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points
Hide Description Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 6
Week 2, AGI; n=57 5
Week 3, AGI; n=61 8
Week 6, AGI; n=47 5
Week 9, AGI; n=41 2
Week 12, AGI; n=31 5
Week 15, AGI; n=22 2
Week 18, AGI; n=17 3
Week 21, AGI; n=14 4
Week 24, AGI; n=11 4
Week 30, AGI; n=9 3
Week 36, AGI; n=5 1
Week 42, AGI; n=4 1
Week 48, AGI; n=3 1
Week 54, AGI; n=2 2
Week 60, AGI; n=2 1
Week 66, AGI; n=1 1
Week 72, AGI; n=1 1
Week 78, AGI; n=1 1
Week 84, AGI; n=1 1
WD/study conclusion, AGI; n=49 8
Worst-case on-therapy, AGI; n=65 21
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 1
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=2 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=49 1
Worst-case on-therapy, ItoG3; n=65 2
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=2 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=49 0
Worst-case on-therapy, ItoG4; n=65 0
13.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 1
Week 2, AGI; n=57 3
Week 3, AGI; n=61 3
Week 6, AGI; n=47 6
Week 9, AGI; n=41 3
Week 12, AGI; n=31 2
Week 15, AGI; n=22 4
Week 18, AGI; n=17 1
Week 21, AGI; n=14 1
Week 24, AGI; n=11 0
Week 30, AGI; n=9 2
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 1
WD/study conclusion, AGI; n=50 7
Worst-case on-therapy, AGI; n=65 16
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3I; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=50 1
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=50 0
Worst-case on-therapy, ItoG4; n=65 0
14.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 1
Week 2, AGI; n=57 0
Week 3, AGI; n=61 2
Week 6, AGI; n=47 3
Week 9, AGI; n=41 2
Week 12, AGI; n=31 2
Week 15, AGI; n=22 2
Week 18, AGI; n=17 0
Week 21, AGI; n=14 0
Week 24, AGI; n=11 0
Week 30, AGI; n=9 0
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
WD/study conclusion, AGI; n=50 0
Worst-case on-therapy, AGI; n=65 10
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3I; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=50 1
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=50 0
Worst-case on-therapy, ItoG4; n=65 0
15.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 0
Week 2, AGI; n=57 2
Week 3, AGI; n=61 1
Week 6, AGI; n=47 2
Week 9, AGI; n=41 8
Week 12, AGI; n=31 3
Week 15, AGI; n=22 3
Week 18, AGI; n=17 2
Week 21, AGI; n=14 3
Week 24, AGI; n=11 3
Week 30, AGI; n=9 4
Week 36, AGI; n=5 1
Week 42, AGI; n=4 1
Week 48, AGI; n=3 1
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 1
Week 78, AGI; n=1 0
Week 84, AGI; n=1 1
WD/study conclusion, AGI; n=50 4
Worst-case on-therapy, AGI; n=65 13
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3I; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=50 1
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=50 0
Worst-case on-therapy, ItoG4; n=65 0
16.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points
Hide Description Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=55 7
Week 2, AGI; n=56 4
Week 3, AGI; n=60 5
Week 6, AGI; n=47 3
Week 9, AGI; n=41 3
Week 12, AGI; n=31 2
Week 15, AGI; n=22 1
Week 18, AGI; n=17 2
Week 21, AGI; n=14 0
Week 24, AGI; n=11 1
Week 30, AGI; n=9 1
Week 36, AGI; n=5 0
Week 42, AGI; n=4 1
Week 48, AGI; n=3 0
Week 54, AGI; n=2 1
Week 60, AGI; n=2 2
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 1
WD/study conclusion, AGI; n=49 12
Worst-case on-therapy, AGI; n=65 23
Week 1, ItoG3; n=55 0
Week 2, ItoG3; n=56 0
Week 3, ItoG3; n=60 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=2 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=49 0
Worst-case on-therapy, ItoG3; n=65 0
Week 1, ItoG4; n=55 0
Week 2, ItoG4; n=56 0
Week 3, ItoG4; n=60 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=2 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=49 0
Worst-case on-therapy, ItoG4; n=65 0
17.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 2
Week 2, AGI; n=56 1
Week 3, AGI; n=61 1
Week 6, AGI; n=47 1
Week 9, AGI; n=40 0
Week 12, AGI; n=31 1
Week 15, AGI; n=22 0
Week 18, AGI; n=17 2
Week 21, AGI; n=14 0
Week 24, AGI; n=11 0
Week 30, AGI; n=9 0
Week 36, AGI; n=5 0
Week 42, AGI; n=4 1
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84 AGI; n=1 0
WD/study conclusion, AGI; n=50 3
Worst-case on-therapy, AGI; n=65 6
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=56 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=40 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=50 0
Worst-case on-therapy, ItoG3; n=65 0
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=56 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=40 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=50 0
Worst-case on-therapy, ItoG4; n=65 0
18.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 13
Week 2, AGI; n=57 10
Week 3, AGI; n=61 10
Week 6, AGI; n=47 7
Week 9, AGI; n=40 6
Week 12, AGI; n=31 4
Week 15, AGI; n=22 3
Week 18, AGI; n=17 1
Week 21, AGI; n=14 1
Week 24, AGI; n=11 2
Week 30, AGI; n=9 0
Week 36, AGI; n=5 1
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 1
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
WD/study conclusion, AGI; n=49 15
Worst-case on-therapy, AGI; n=65 32
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=57 0
Week 3, ItoG3; n=61 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=40 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=14 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=49 1
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=57 0
Week 3, ItoG4; n=61 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=40 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=14 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=49 0
Worst-case on-therapy, ItoG4; n=65 0
19.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points
Hide Description Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 9
Week 2, AGI; n=54 3
Week 3, AGI; n=59 5
Week 6, AGI; n=46 3
Week 9, AGI; n=41 4
Week 12, AGI; n=31 4
Week 15, AGI; n=22 1
Week 18, AGI; n=17 2
Week 21, AGI; n=13 1
Week 24, AGI; n=11 0
Week 30, AGI; n=9 2
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
WD/study conclusion, AGI; n=48 7
Worst-case on-therapy, AGI; n=65 25
Week 1, ItoG3; n=54 1
Week 2, ItoG3; n=54 0
Week 3, ItoG3; n=59 1
Week 6, ItoG3; n=46 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=13 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=48 2
Worst-case on-therapy, ItoG3; n=65 5
Week 1, ItoG4; n=54 0
Week 2, ItoG4; n=54 0
Week 3, ItoG4; n=59 0
Week 6, ItoG4; n=46 0
Week 9, ItoG4; n=41 1
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=13 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=48 0
Worst-case on-therapy, ItoG4; n=65 1
20.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points
Hide Description Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=33 1
Week 2, AGI; n=33 6
Week 3, AGI; n=44 3
Week 6, AGI; n=37 4
Week 9, AGI; n=36 1
Week 12, AGI; n=27 0
Week 15, AGI; n=18 1
Week 18, AGI; n=16 1
Week 21, AGI; n=11 0
Week 24, AGI; n=9 0
Week 30, AGI; n=9 0
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=2 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
WD/study conclusion, AGI; n=35 6
Worst-case on-therapy, AGI; n=59 17
Week 1, ItoG3; n=33 0
Week 2, ItoG3; n=33 0
Week 3, ItoG3; n=44 0
Week 6, ItoG3; n=37 1
Week 9, ItoG3; n=36 0
Week 12, ItoG3; n=27 0
Week 15, ItoG3; n=18 0
Week 18, ItoG3; n=16 0
Week 21, ItoG3; n=11 0
Week 24, ItoG3; n=9 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=2 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=35 1
Worst-case on-therapy, ItoG3; n=59 2
Week 1, ItoG4; n=33 0
Week 2, ItoG4; n=33 0
Week 3, ItoG4; n=44 0
Week 6, ItoG4; n=37 0
Week 9, ItoG4; n=36 0
Week 12, ItoG4; n=27 0
Week 15, ItoG4; n=18 0
Week 18, ItoG4; n=16 0
Week 21, ItoG4; n=11 0
Week 24, ItoG4; n=9 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=2 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=35 0
Worst-case on-therapy, ItoG4; n=59 0
21.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points
Hide Description Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=54 9
Week 2, AGI; n=53 7
Week 3, AGI; n=59 5
Week 6, AGI; n=47 7
Week 9, AGI; n=41 4
Week 12, AGI; n=31 1
Week 15, AGI; n=22 3
Week 18, AGI; n=17 1
Week 21, AGI; n=13 0
Week 24, AGI; n=11 1
Week 30, AGI; n=9 2
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
WD/study conclusion, AGI; n=48 10
Worst-case on-therapy, AGI; n=65 28
Week 1, ItoG3; n=54 0
Week 2, ItoG3; n=53 1
Week 3, ItoG3; n=59 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 1
Week 12, ItoG3; n=31 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=13 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 1
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
WD/study conclusion, ItoG3; n=48 2
Worst-case on-therapy, ItoG3; n=65 4
Week 1, ItoG4; n=54 1
Week 2, ItoG4; n=53 0
Week 3, ItoG4; n=59 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=31 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=13 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
WD/study conclusion, ItoG4; n=48 0
Worst-case on-therapy, ItoG4; n=65 1
22.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=62 10
Week 2, AGI; n=64 16
Week 3, AGI; n=62 12
Week 6, AGI; n=47 10
Week 9, AGI; n=41 7
Week 12, AGI; n=30 6
Week 15, AGI; n=22 5
Week 18, AGI; n=17 2
Week 21, AGI; n=13 4
Week 24, AGI; n=11 3
Week 30, AGI; n=9 3
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
Withdrawal/study conclusion, AGI; n=51 16
Worst-case on-therapy, AGI; n=65 33
Week 1, ItoG3; n=62 0
Week 2, ItoG3; n=64 0
Week 3, ItoG3; n=62 0
Week 6, ItoG3; n=47 1
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=30 0
Week 15, ItoG3; n=22 1
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=13 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
Withdrawal/study conclusion, ItoG3; n=51 5
Worst-case on-therapy, ItoG3; n=65 9
Week 1, ItoG4; n=62 0
Week 2, ItoG4; n=64 0
Week 3, ItoG4; n=62 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=30 1
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=13 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
Withdrawal/study conclusion, ItoG4; n=51 0
Worst-case on-therapy, ItoG4; n=65 1
23.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=14 0
Week 2, AGI; n=16 0
Week 3, AGI; n=16 0
Week 6, AGI; n=12 0
Week 9, AGI; n=11 0
Week 12, AGI; n=7 0
Week 15, AGI; n=6 0
Week 18, AGI; n=5 0
Week 21, AGI; n=4 2
Week 24, AGI; n=3 0
Week 30, AGI; n=2 0
Week 36, AGI; n=1 0
Week 42, AGI; n=0 0
Week 48, AGI; n=0 0
Week 54, AGI; n=0 0
Week 60, AGI; n=0 0
Week 66, AGI; n=0 0
Week 72, AGI; n=0 0
Week 78, AGI; n=0 0
Week 84, AGI; n=0 0
Withdrawal/study conclusion, AGI; n=10 1
Worst-case on-therapy, AGI; n=16 3
Week 1, ItoG3; n=14 0
Week 2, ItoG3; n=16 0
Week 3, ItoG3; n=16 0
Week 6, ItoG3; n=12 0
Week 9, ItoG3; n=11 0
Week 12, ItoG3; n=7 0
Week 15, ItoG3; n=6 0
Week 18, ItoG3; n=5 0
Week 21, ItoG3; n=4 0
Week 24, ItoG3; n=3 0
Week 30, ItoG3; n=2 0
Week 36, ItoG3; n=1 0
Week 42, ItoG3; n=0 0
Week 48, ItoG3; n=0 0
Week 54, ItoG3; n=0 0
Week 60, ItoG3; n=0 0
Week 66, ItoG3; n=0 0
Week 72, ItoG3; n=0 0
Week 78, ItoG3; n=0 0
Week 84, ItoG3; n=0 0
Withdrawal/study conclusion, ItoG3; n=10 0
Worst-case on-therapy, ItoG3; n=16 0
Week 1, ItoG4; n=14 0
Week 2, ItoG4; n=16 0
Week 3, ItoG4; n=16 0
Week 6, ItoG4; n=12 0
Week 9, ItoG4; n=11 0
Week 12, ItoG4; n=7 0
Week 15, ItoG4; n=6 0
Week 18, ItoG4; n=5 0
Week 21, ItoG4; n=4 0
Week 24, ItoG4; n=3 0
Week 30, ItoG4; n=2 0
Week 36, ItoG4; n=1 0
Week 42, ItoG4; n=0 0
Week 48, ItoG4; n=0 0
Week 54, ItoG4; n=0 0
Week 60, ItoG4; n=0 0
Week 66, ItoG4; n=0 0
Week 72, ItoG4; n=0 0
Week 78, ItoG4; n=0 0
Week 84, ItoG4; n=0 0
Withdrawal/study conclusion, ItoG4; n=10 0
Worst-case on-therapy, ItoG4; n=16 0
24.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=15 0
Week 2, AGI; n=17 1
Week 3, AGI; n=17 1
Week 6, AGI; n=12 1
Week 9, AGI; n=11 1
Week 12, AGI; n=7 1
Week 15, AGI; n=6 1
Week 18, AGI; n=5 1
Week 21, AGI; n=4 2
Week 24, AGI; n=3 0
Week 30, AGI; n=2 0
Week 36, AGI; n=1 0
Week 42, AGI; n=0 0
Week 48, AGI; n=0 0
Week 54, AGI; n=0 0
Week 60, AGI; n=0 0
Week 66, AGI; n=0 0
Week 72, AGI; n=0 0
Week 78, AGI; n=0 0
Week 84, AGI; n=0 0
Withdrawal/study conclusion,, AGI; n=12 1
Worst-case on-therapy, AGI; n=17 3
Week 1, ItoG3; n=15 0
Week 2, ItoG3; n=17 0
Week 3, ItoG3; n=17 0
Week 6, ItoG3; n=12 0
Week 9, ItoG3; n=11 0
Week 12, ItoG3; n=7 0
Week 15, ItoG3; n=6 0
Week 18, ItoG3; n=5 0
Week 21, ItoG3; n=4 0
Week 24, ItoG3; n=3 0
Week 30, ItoG3; n=2 0
Week 36, ItoG3; n=1 0
Week 42, ItoG3; n=0 0
Week 48, ItoG3; n=0 0
Week 54, ItoG3; n=0 0
Week 60, ItoG3; n=0 0
Week 66, ItoG3; n=0 0
Week 72, ItoG3; n=0 0
Week 78, ItoG3; n=0 0
Week 84, ItoG3; n=0 0
Withdrawal/study conclusion, ItoG3; n=12 0
Worst-case on-therapy, ItoG3; n=17 0
Week 1, ItoG4; n=15 0
Week 2, ItoG4; n=17 0
Week 3, ItoG4; n=17 0
Week 6, ItoG4; n=12 0
Week 9, ItoG4; n=11 0
Week 12, ItoG4; n=7 0
Week 15, ItoG4; n=6 0
Week 18, ItoG4; n=5 0
Week 21, ItoG4; n=4 0
Week 24, ItoG4; n=3 0
Week 30, ItoG4; n=2 0
Week 36, ItoG4; n=1 0
Week 42, ItoG4; n=0 0
Week 48, ItoG4; n=0 0
Week 54, ItoG4; n=0 0
Week 60, ItoG4; n=0 0
Week 66, ItoG4; n=0 0
Week 72, ItoG4; n=0 0
Week 78, ItoG4; n=0 0
Week 84, ItoG4; n=0 0
Withdrawal/study conclusion, ItoG4; n=12 0
Worst-case on-therapy, ItoG4; n=17 0
25.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=62 1
Week 2, AGI; n=64 2
Week 3, AGI; n=62 0
Week 6, AGI; n=47 2
Week 9, AGI; n=41 3
Week 12, AGI; n=30 2
Week 15, AGI; n=22 2
Week 18, AGI; n=17 0
Week 21, AGI; n=13 1
Week 24, AGI; n=11 0
Week 30, AGI; n=9 2
Week 36, AGI; n=5 0
Week 42, AGI; n=4 0
Week 48, AGI; n=3 0
Week 54, AGI; n=3 0
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
Withdrawal/study conclusion, AGI; n=51 4
Worst-case on-therapy, AGI; n=65 10
Week 1, ItoG3; n=62 0
Week 2, ItoG3; n=64 0
Week 3, ItoG3; n=62 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=30 0
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=13 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
Withdrawal/study conclusion, ItoG3; n=51 0
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=62 0
Week 2, ItoG4; n=64 0
Week 3, ItoG4; n=62 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=30 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=13 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
Withdrawal/study conclusion, ItoG4; n=51 0
Worst-case on-therapy, ItoG4; n=65 0
26.Secondary Outcome
Title Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points
Hide Description Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time Frame Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were evaluated.
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description:
Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Week 1, AGI; n=62 5
Week 2, AGI; n=64 9
Week 3, AGI; n=62 6
Week 6, AGI; n=47 5
Week 9, AGI; n=41 3
Week 12, AGI; n=30 7
Week 15, AGI; n=22 4
Week 18, AGI; n=17 3
Week 21, AGI; n=13 3
Week 24, AGI; n=11 1
Week 30, AGI; n=9 3
Week 36, AGI; n=5 2
Week 42, AGI; n=4 2
Week 48, AGI; n=3 1
Week 54, AGI; n=3 1
Week 60, AGI; n=2 0
Week 66, AGI; n=1 0
Week 72, AGI; n=1 0
Week 78, AGI; n=1 0
Week 84, AGI; n=1 0
Withdrawal/study conclusion, AGI; n=51 2
Worst-case on-therapy, AGI; n=65 17
Week 1, ItoG3; n=62 0
Week 2, ItoG3; n=64 0
Week 3, ItoG3; n=62 0
Week 6, ItoG3; n=47 0
Week 9, ItoG3; n=41 0
Week 12, ItoG3; n=30 1
Week 15, ItoG3; n=22 0
Week 18, ItoG3; n=17 0
Week 21, ItoG3; n=13 0
Week 24, ItoG3; n=11 0
Week 30, ItoG3; n=9 0
Week 36, ItoG3; n=5 0
Week 42, ItoG3; n=4 0
Week 48, ItoG3; n=3 0
Week 54, ItoG3; n=3 0
Week 60, ItoG3; n=2 0
Week 66, ItoG3; n=1 0
Week 72, ItoG3; n=1 0
Week 78, ItoG3; n=1 0
Week 84, ItoG3; n=1 0
Withdrawal/study conclusion, ItoG3; n=51 0
Worst-case on-therapy, ItoG3; n=65 1
Week 1, ItoG4; n=62 0
Week 2, ItoG4; n=64 0
Week 3, ItoG4; n=62 0
Week 6, ItoG4; n=47 0
Week 9, ItoG4; n=41 0
Week 12, ItoG4; n=30 0
Week 15, ItoG4; n=22 0
Week 18, ItoG4; n=17 0
Week 21, ItoG4; n=13 0
Week 24, ItoG4; n=11 0
Week 30, ItoG4; n=9 0
Week 36, ItoG4; n=5 0
Week 42, ItoG4; n=4 0
Week 48, ItoG4; n=3 0
Week 54, ItoG4; n=3 0
Week 60, ItoG4; n=2 0
Week 66, ItoG4; n=1 0
Week 72, ItoG4; n=1 0
Week 78, ItoG4; n=1 0
Week 84, ItoG4; n=1 0
Withdrawal/study conclusion, ItoG4; n=51 0
Worst-case on-therapy, ItoG4; n=65 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib + Capecitabine
Hide Arm/Group Description Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
All-Cause Mortality
Lapatinib + Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib + Capecitabine
Affected / at Risk (%)
Total   22/67 (32.84%) 
Blood and lymphatic system disorders   
Anemia  1  2/67 (2.99%) 
Cardiac disorders   
Acute myocardial infarction  1  1/67 (1.49%) 
Gastrointestinal disorders   
Vomiting  1  4/67 (5.97%) 
Diarrhea  1  3/67 (4.48%) 
Nausea  1  2/67 (2.99%) 
Abdominal distension  1  1/67 (1.49%) 
Abdominal pain  1  1/67 (1.49%) 
Dyspepsia  1  1/67 (1.49%) 
Gastrointestinal hemorrhage  1  1/67 (1.49%) 
Gastroesophageal reflux disease  1  1/67 (1.49%) 
Ileus  1  1/67 (1.49%) 
Obstruction gastric  1  1/67 (1.49%) 
Upper gastrointestinal hemorrhage  1  1/67 (1.49%) 
General disorders   
Fatigue  1  1/67 (1.49%) 
Pyrexia  1  1/67 (1.49%) 
Hepatobiliary disorders   
Jaundice  1  1/67 (1.49%) 
Infections and infestations   
Pneumonia  1  1/67 (1.49%) 
Injury, poisoning and procedural complications   
Poisoning  1  1/67 (1.49%) 
Postoperative hernia  1  1/67 (1.49%) 
Investigations   
Ejection fraction decreased  1  1/67 (1.49%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/67 (4.48%) 
Hyponatremia  1  1/67 (1.49%) 
Hypophagia  1  1/67 (1.49%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/67 (1.49%) 
Pulmonary thrombosis  1  1/67 (1.49%) 
Vascular disorders   
Embolism  1  1/67 (1.49%) 
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 + Capecitabine
Affected / at Risk (%)
Total   63/67 (94.03%) 
Blood and lymphatic system disorders   
Anemia  1  16/67 (23.88%) 
Neutropenia  1  5/67 (7.46%) 
Hemoglobin decreased  1  4/67 (5.97%) 
Lymphopenia  1  4/67 (5.97%) 
Thrombocytopenia  1  4/67 (5.97%) 
Gastrointestinal disorders   
Diarrhea  1  27/67 (40.30%) 
Nausea  1  23/67 (34.33%) 
Abdominal pain  1  13/67 (19.40%) 
Abdominal pain upper  1  12/67 (17.91%) 
Vomiting  1  12/67 (17.91%) 
Constipation  1  8/67 (11.94%) 
Stomatitis  1  8/67 (11.94%) 
Pyrexia  1  7/67 (10.45%) 
Abdominal discomfort  1  4/67 (5.97%) 
Dyspepsia  1  4/67 (5.97%) 
Mouth ulceration  1  4/67 (5.97%) 
General disorders   
Fatigue  1  23/67 (34.33%) 
Asthenia  1  11/67 (16.42%) 
Edema peripheral  1  8/67 (11.94%) 
Pain  1  5/67 (7.46%) 
Investigations   
Weight decreased  1  11/67 (16.42%) 
Aspartate aminotransferase increased  1  9/67 (13.43%) 
Alanine aminotransferase increased  1  8/67 (11.94%) 
Blood creatinine increased  1  5/67 (7.46%) 
Metabolism and nutrition disorders   
Decreased appetite  1  23/67 (34.33%) 
Hypoalbuminemia  1  9/67 (13.43%) 
Hypocalcemia  1  5/67 (7.46%) 
Hypokalemia  1  5/67 (7.46%) 
Hyponatremia  1  5/67 (7.46%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  6/67 (8.96%) 
Nervous system disorders   
Dizziness  1  9/67 (13.43%) 
Headache  1  4/67 (5.97%) 
Psychiatric disorders   
Insomnia  1  6/67 (8.96%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/67 (13.43%) 
Dyspnea  1  6/67 (8.96%) 
Rhinorrhea  1  6/67 (8.96%) 
Hiccups  1  4/67 (5.97%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome  1  17/67 (25.37%) 
Rash  1  10/67 (14.93%) 
Dry skin  1  5/67 (7.46%) 
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: NCT00526669     History of Changes
Other Study ID Numbers: LPT109747
First Submitted: September 6, 2007
First Posted: September 10, 2007
Results First Submitted: February 16, 2012
Results First Posted: October 1, 2012
Last Update Posted: January 29, 2016