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Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric 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: NCT00486954
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : February 7, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Gastrointestinal Tract
Interventions Drug: Lapatinib
Drug: Paclitaxel
Enrollment 273
Recruitment Details This study consisted of a Pilot part and a Randomized part. The Pilot part and the Randomized part had two separate participant (par.) populations. The study period of the Randomized part was from 31 March 2008 to 5 January 2012 (cut-off date for efficacy). Follow-up was conducted until 30 October 2012 (cut-off date for safety analysis).
Pre-assignment Details In the Pilot part, par. were enrolled in this study based on their gastrectomy status: non-gastrectomy (intact stomach), partial gastrectomy (gastrectomy with pylorus preserved), and gastrectomy (pylorus removed). However, no par. with partial gastrectomy were enrolled. In the Randomized part, par. were randomized to two treatment arms.
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2). Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort. Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Period Title: Pilot Part
Started 6 0 6 0 0
Completed 0 0 0 0 0
Not Completed 6 0 6 0 0
Reason Not Completed
Adverse Event             4             0             5             0             0
Disease Progression             2             0             1             0             0
Period Title: Randomized Part
Started 0 0 0 132 129
Completed 0 0 0 112 115
Not Completed 0 0 0 20 14
Reason Not Completed
Lost to Follow-up             0             0             0             0             1
Withdrawal by Subject             0             0             0             1             0
Sponsor Terminated Study             0             0             0             19             13
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel in Randomized Part Paclitaxel Alone in Randomized Part Total
Hide Arm/Group Description In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2). In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle). Total of all reporting groups
Overall Number of Baseline Participants 6 6 132 129 273
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 132 participants 129 participants 273 participants
57.5  (11.31) 57.2  (10.98) 60.8  (9.45) 60.4  (10.96) 60.5  (10.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 132 participants 129 participants 273 participants
Female
1
  16.7%
0
   0.0%
31
  23.5%
23
  17.8%
55
  20.1%
Male
5
  83.3%
6
 100.0%
101
  76.5%
106
  82.2%
218
  79.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 132 participants 129 participants 273 participants
Asian - Japanese Heritage 6 6 52 48 112
Asian - East Asian Heritage 0 0 73 75 148
Asian - South East Asian Heritage 0 0 7 6 13
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
Hide Description DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.
Time Frame 28 days
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Hide Analysis Population Description
Safety Population (Pilot part): all participants who received at least one dose of investigational product in the Pilot part of the study
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
2 1
2.Primary Outcome
Title Overall Survival (OS) in the Randomized Part of the Study
Hide Description OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.
Time Frame From randomization until death due to any cause (up to 42.58 months)
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Hide Analysis Population Description
Intent-to-Treat Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 132 129
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.5 to 14.5)
8.9
(7.4 to 11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib Plus Paclitaxel, Paclitaxel Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2088
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.64 to 1.11
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study
Hide Description Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.
Time Frame Days 8 and 14
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Hide Analysis Population Description
PK Parameter Population: all participants for whom the PK parameter could be estimated
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: nanograms per milliliter (ng/mL)
Day 8
5435.525
(3932.949 to 7512.158)
3129.561
(2429.401 to 4031.507)
Day 14
3930.780
(3239.218 to 4769.988)
2062.557
(1301.258 to 3269.251)
4.Secondary Outcome
Title Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study
Hide Description PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.
Time Frame Days 8 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: hours (hr)
Day 8
4.083
(2.98 to 8.00)
3.500
(2.97 to 6.05)
Day 14
7.992
(3.10 to 11.97)
4.000
(3.03 to 4.08)
5.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study
Hide Description PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.
Time Frame Days 8 and 14
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Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*ng/mL
Day 8
86584.045
(71317.921 to 105117.994)
37332.880
(27185.084 to 51268.700)
Day 14
68177.402
(54550.364 to 85208.564)
30565.248
(18109.123 to 51589.156)
6.Secondary Outcome
Title Cmax of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.
Time Frame Days 1 and 8
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Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Day 1
4121.513
(3524.391 to 4819.803)
2731.104
(2275.497 to 3277.934)
Day 8
4610.176
(3896.911 to 5453.992)
2949.770
(2695.770 to 3227.702)
7.Secondary Outcome
Title Tmax of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: hr
Day 1
1.042
(1.00 to 1.42)
1.075
(0.98 to 1.25)
Day 8
1.050
(1.00 to 1.18)
1.025
(1.00 to 1.07)
8.Secondary Outcome
Title AUC(0-24) of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*ng/mL
Day 1
5771.847
(4726.425 to 7048.502)
3968.654
(3531.979 to 4459.317)
Day 8
7492.825
(6182.574 to 9080.754)
4992.934
(4432.158 to 5624.660)
9.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr*ng/mL
Day 1
6262.157
(5042.138 to 7777.378)
4058.648
(3952.209 to 5143.429)
Day 8
8340.326
(6835.815 to 10175.970)
6020.878
(4347.656 to 8338.049)
10.Secondary Outcome
Title Half-life of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
Day 1
10.128
(8.886 to 11.543)
13.053
(10.266 to 16.597)
Day 8
10.342
(8.460 to 12.642)
13.978
(7.748 to 25.219)
11.Secondary Outcome
Title Clearance of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: liters per hour per square meter
Day 1
12.775
(10.286 to 15.866)
17.744
(15.554 to 20.242)
Day 8
9.592
(7.862 to 11.703)
13.287
(9.595 to 18.401)
12.Secondary Outcome
Title Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study
Hide Description PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.
Time Frame Days 1 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants
Hide Arm/Group Description:
Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
Overall Number of Participants Analyzed 6 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: liters per square meter
Day 1
76.011
(67.170 to 86.015)
141.196
(110.329 to 180.698)
Day 8
71.223
(55.644 to 91.163)
126.121
(79.776 to 199.391)
13.Secondary Outcome
Title Progression-free Survival (PFS) in the Randomized Part of the Study
Hide Description PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time Frame From randomization until disease progression or death due to any cause (up to 42.35 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. For participants whose disease did not progress or who did not die, PFS was censored at the time of the last independently assessed radiological scan preceding the initiation of any alternate anti-cancer therapy.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 132 129
Median (95% Confidence Interval)
Unit of Measure: months
5.4
(3.9 to 5.7)
4.4
(3.7 to 5.6)
14.Secondary Outcome
Title Time to Progression in the Randomized Part of the Study
Hide Description Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time Frame From randomization until disease progression or death due to disease (up to 42.35 months )
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Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 132 129
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(3.9 to 5.8)
4.4
(3.7 to 5.6)
15.Secondary Outcome
Title Percentage of Participants With Overall Response in the Randomized Part of the Study
Hide Description Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time Frame From randomization up to 5.62 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 132 129
Measure Type: Number
Unit of Measure: Percentage of participants
27 9
16.Secondary Outcome
Title Number of Participants With the Indicated Time to Response in the Randomized Part of the Study
Hide Description Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.
Time Frame up to 5.62 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants achieving a CR or PR were assessed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 35 11
Measure Type: Number
Unit of Measure: Participants
Weeks 1-8 13 5
Weeks >8 - 16 20 3
Weeks >16 - 24 1 3
Weeks >24 - 32 1 0
17.Secondary Outcome
Title Duration of Response in the Randomized Part of the Study
Hide Description Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.
Time Frame up to 18.27 months
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ITT Population. Only those participants achieving a CR or PR were assessed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 35 11
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(5.0 to 11.0)
5.1
(3.7 to 11.2)
18.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study
Hide Description The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.
Time Frame From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)
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Safety Population: all participants who were randomized and took at least one dose of study medication
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 131 129
Measure Type: Number
Unit of Measure: participants
Diarrhoea, Grade 3 23 3
Diarrhoea, Grade 4 1 0
Nausea, Grade 3 5 3
Nausea, Grade 4 0 0
Vomiting, Grade 3 4 4
Vomiting, Grade 4 0 0
Stomatitis, Grade 3 2 1
Stomatitis, Grade 4 0 0
Constipation, Grade 3 0 1
Constipation, Grade 4 0 0
Abdominal pain, Grade 3 0 0
Abdominal pain, Grade 4 0 0
Neutropenia, Grade 3 41 33
Neutropenia, Grade 4 34 6
Leukopenia, Grade 3 32 12
Leukopenia, Grade 4 7 1
Anaemia, Grade 3 10 8
Anaemia, Grade 4 4 1
Lymphopenia, Grade 3 4 2
Lymphopenia, Grade 4 1 1
Alopecia, Grade 3 0 0
Alopecia, Grade 4 0 0
Rash, Grade 3 3 0
Rash, Grade 4 0 0
Pruritus, Grade 3 0 0
Pruritus, Grade 4 0 0
Fatigue, Grade 3 6 1
Fatigue, Grade 4 0 0
Pyrexia, Grade 3 1 1
Pyrexia, Grade 4 0 0
Asthenia, Grade 3 1 0
Asthenia, Grade 4 0 0
Weight decreased, Grade 3 2 0
Weight decreased, Grade 4 0 0
White blood cell count decreased, Grade 3 18 6
White blood cell count decreased, Grade 4 1 1
Neutrophil count decreased, Grade 3 11 4
Neutrophil count decreased, Grade 4 5 2
Haemoglobin decreased, Grade 3 9 5
Haemoglobin decreased, Grade (G) 4 1 0
Aspartate aminotransferase increased, G 3 1 1
Aspartate aminotransferase increased, G 4 1 0
Alanine aminotransferase increased, G 3 2 2
Alanine aminotransferase increased, G 4 1 0
Peripheral sensory neuropathy, G 3 1 0
Peripheral sensory neuropathy, G 4 0 0
Neuropathy peripheral, Grade 3 2 1
Neuropathy peripheral, Grade 4 0 0
Decreased appetite, Grade 3 11 9
Decreased appetite, Grade 4 1 0
Myalgia, Grade 3 0 0
Myalgia, Grade 4 0 0
Arthralgia, Grade 3 2 0
Arthralgia, Grade 4 0 0
Back pain, Grade 3 0 0
Back pain, Grade 4 0 0
19.Secondary Outcome
Title Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-12.41  (25.578) -11.55  (28.562)
20.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-13.48  (18.776) -13.99  (21.087)
21.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-17.41  (24.468) -18.31  (27.625)
22.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-10.65  (19.594) -10.12  (22.066)
23.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-10.19  (16.133) -12.14  (20.446)
24.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-10.74  (26.122) -13.33  (22.089)
25.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
11.98  (21.084) 14.79  (23.885)
26.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.26  (17.411) 7.28  (19.666)
27.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
7.41  (27.038) 12.68  (29.743)
28.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
12.22  (22.037) 15.02  (23.764)
29.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.56  (28.813) 10.80  (27.473)
30.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
12.59  (28.521) 7.04  (28.683)
31.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.93  (27.176) 2.35  (26.621)
32.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.00  (31.385) 4.29  (24.025)
33.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
7.04  (28.042) 0.95  (27.200)
34.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.37  (21.382) 5.16  (14.887)
35.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.46  (16.151) 3.40  (14.542)
36.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.33  (14.177) 2.66  (15.312)
37.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.33  (18.780) 6.69  (18.720)
38.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.27  (24.624) 2.97  (21.899)
39.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.15  (27.053) 2.35  (21.324)
40.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
13.70  (28.659) 3.29  (0)
41.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 90 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
15.99  (27.442) 8.45  (32.229)
42.Secondary Outcome
Title Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study
Hide Description The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.
Time Frame Baseline and end of therapy (up to 42.58 months)
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Hide Analysis Population Description
ITT Population. Only those participants who contributed data were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 22 13
Mean (Standard Deviation)
Unit of Measure: scores on a scale
9.09  (31.171) 7.69  (33.758)
43.Secondary Outcome
Title Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study
Hide Description EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.
Time Frame Pretreatment
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Hide Analysis Population Description
ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
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Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 73 65
Measure Type: Number
Unit of Measure: participants
<3+ 68 59
3+ 5 6
44.Secondary Outcome
Title Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study
Hide Description HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, "HER2 negative"; score of 2+, "borderline"; score of 3+, "HER2 positive."
Time Frame Pretreatment
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Hide Analysis Population Description
ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 100 92
Measure Type: Number
Unit of Measure: participants
0/1+ 36 32
2+ 12 11
3+ 52 49
45.Secondary Outcome
Title Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib
Hide Description An inadequate number of tissue samples were obtained; thus, analysis could not be performed.
Time Frame Pretreatment
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ITT Population
Arm/Group Title Lapatinib Plus Paclitaxel Paclitaxel Alone
Hide Arm/Group Description:
Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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 51.7 weeks in the Pilot part and up to 110.3 weeks in the Randomized part).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population in both the Pilot part and the Randomized part . For the Pilot part, MedDRA 12.1 was used; for the Randomized part, MedDRa 15.1 was used.
 
Arm/Group Title Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel in Randomized Part Paclitaxel Alone in Randomized Part
Hide Arm/Group Description In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2). In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
All-Cause Mortality
Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel in Randomized Part Paclitaxel Alone in Randomized Part
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel in Randomized Part Paclitaxel Alone in Randomized Part
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   2/6 (33.33%)   38/131 (29.01%)   20/129 (15.50%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  0/6 (0.00%)  0/6 (0.00%)  8/131 (6.11%)  2/129 (1.55%) 
Neutropenia  1  0/6 (0.00%)  0/6 (0.00%)  4/131 (3.05%)  0/129 (0.00%) 
Anaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Leukopenia  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Cardiac disorders         
Acute left ventricular failure  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Acute myocardial infarction  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Cardiac arrest  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Left ventricular dysfunction  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Endocrine disorders         
Hypothyroidism  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Eye disorders         
Cataract  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Gastrointestinal disorders         
Diarrhoea  1  1/6 (16.67%)  1/6 (16.67%)  3/131 (2.29%)  0/129 (0.00%) 
Abdominal pain  1  0/6 (0.00%)  0/6 (0.00%)  3/131 (2.29%)  0/129 (0.00%) 
Ileus  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  2/129 (1.55%) 
Intestinal obstruction  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Vomiting  1  0/6 (0.00%)  0/6 (0.00%)  2/131 (1.53%)  0/129 (0.00%) 
Constipation  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Gastrointestinal haemorrhage  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Gastrointestinal obstruction  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Gastrointestinal perforation  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Ileus paralytic  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Melaena  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Subileus  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Nausea  1  0/6 (0.00%)  0/6 (0.00%)  3/131 (2.29%)  0/129 (0.00%) 
General disorders         
Pyrexia  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Asthenia  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Death  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Oedema peripheral  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Infections and infestations         
Pneumonia  1  0/6 (0.00%)  1/6 (16.67%)  2/131 (1.53%)  4/129 (3.10%) 
Enterocolitis infectious  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Beta haemolytic streptococcal infection  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Device related infection  1  0/6 (0.00%)  0/6 (0.00%)  2/131 (1.53%)  1/129 (0.78%) 
Herpes zoster  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Infection  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Cellulitis  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Cholangitis suppurative  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Pneumonia pneumococcal  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Sepsis  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Hand fracture  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Investigations         
Haemoglobin decreased  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/6 (16.67%)  0/6 (0.00%)  5/131 (3.82%)  2/129 (1.55%) 
Dehydration  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Hypoalbuminaemia  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Hypokalaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Arthralgia  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Nervous system disorders         
Peripheral sensory neuropathy  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Cerebral infarction  1  0/6 (0.00%)  0/6 (0.00%)  0/131 (0.00%)  1/129 (0.78%) 
Respiratory, thoracic and mediastinal disorders         
Interstitial lung disease  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Embolism  1  0/6 (0.00%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib Plus Paclitaxel in Non-gastrectomy Participants Lapatinib Plus Paclitaxel in Gastrectomy Participants Lapatinib Plus Paclitaxel in Randomized Part Paclitaxel Alone in Randomized Part
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   131/131 (100.00%)   126/129 (97.67%) 
Blood and lymphatic system disorders         
Neutropenia  1  6/6 (100.00%)  5/6 (83.33%)  85/131 (64.89%)  64/129 (49.61%) 
Anaemia  1  5/6 (83.33%)  1/6 (16.67%)  45/131 (34.35%)  27/129 (20.93%) 
Leukopenia  1  5/6 (83.33%)  4/6 (66.67%)  67/131 (51.15%)  54/129 (41.86%) 
Lymphopenia  1  5/6 (83.33%)  3/6 (50.00%)  17/131 (12.98%)  15/129 (11.63%) 
Monocytopenia  1  0/6 (0.00%)  1/6 (16.67%)  3/131 (2.29%)  1/129 (0.78%) 
Cardiac disorders         
Sinus tachycardia  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Supraventricular tachycardia  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Eye disorders         
Visual acuity reduced  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Gastrointestinal disorders         
Nausea  1  6/6 (100.00%)  1/6 (16.67%)  46/131 (35.11%)  35/129 (27.13%) 
Diarrhoea  1  5/6 (83.33%)  5/6 (83.33%)  100/131 (76.34%)  29/129 (22.48%) 
Stomatitis  1  3/6 (50.00%)  2/6 (33.33%)  41/131 (31.30%)  18/129 (13.95%) 
Vomiting  1  3/6 (50.00%)  1/6 (16.67%)  38/131 (29.01%)  23/129 (17.83%) 
Abdominal discomfort  1  1/6 (16.67%)  0/6 (0.00%)  6/131 (4.58%)  3/129 (2.33%) 
Abdominal distension  1  1/6 (16.67%)  1/6 (16.67%)  8/131 (6.11%)  7/129 (5.43%) 
Anal haemorrhage  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Cheilitis  1  1/6 (16.67%)  1/6 (16.67%)  5/131 (3.82%)  1/129 (0.78%) 
Gastric ulcer  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Constipation  1  0/6 (0.00%)  0/6 (0.00%)  15/131 (11.45%)  26/129 (20.16%) 
Abdominal pain  1  0/6 (0.00%)  0/6 (0.00%)  17/131 (12.98%)  8/129 (6.20%) 
Abdominal pain upper  1  0/6 (0.00%)  0/6 (0.00%)  10/131 (7.63%)  8/129 (6.20%) 
Dyspepsia  1  0/6 (0.00%)  0/6 (0.00%)  9/131 (6.87%)  2/129 (1.55%) 
General disorders         
Pyrexia  1  4/6 (66.67%)  2/6 (33.33%)  36/131 (27.48%)  16/129 (12.40%) 
Fatigue  1  3/6 (50.00%)  4/6 (66.67%)  56/131 (42.75%)  48/129 (37.21%) 
Chills  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  3/129 (2.33%) 
Oedema  1  1/6 (16.67%)  1/6 (16.67%)  5/131 (3.82%)  3/129 (2.33%) 
Thirst  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Influenza like illness  1  0/6 (0.00%)  1/6 (16.67%)  3/131 (2.29%)  5/129 (3.88%) 
Oedema peripheral  1  0/6 (0.00%)  1/6 (16.67%)  6/131 (4.58%)  8/129 (6.20%) 
Asthenia  1  0/6 (0.00%)  0/6 (0.00%)  20/131 (15.27%)  8/129 (6.20%) 
Malaise  1  0/6 (0.00%)  0/6 (0.00%)  8/131 (6.11%)  4/129 (3.10%) 
Hepatobiliary disorders         
Biliary dilatation  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Hepatic function abnormal  1  1/6 (16.67%)  0/6 (0.00%)  7/131 (5.34%)  1/129 (0.78%) 
Hyperbilirubinaemia  1  1/6 (16.67%)  3/6 (50.00%)  8/131 (6.11%)  3/129 (2.33%) 
Infections and infestations         
Infection  1  1/6 (16.67%)  1/6 (16.67%)  7/131 (5.34%)  1/129 (0.78%) 
Nasopharyngitis  1  1/6 (16.67%)  0/6 (0.00%)  10/131 (7.63%)  9/129 (6.98%) 
Paronychia  1  1/6 (16.67%)  0/6 (0.00%)  13/131 (9.92%)  0/129 (0.00%) 
Pneumonia  1  1/6 (16.67%)  0/6 (0.00%)  4/131 (3.05%)  4/129 (3.10%) 
Bronchitis  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Neutropenic infection  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  0/6 (0.00%)  10/131 (7.63%)  5/129 (3.88%) 
Injury, poisoning and procedural complications         
Post gastric surgery syndrome  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  3/6 (50.00%)  4/6 (66.67%)  16/131 (12.21%)  11/129 (8.53%) 
Aspartate aminotransferase increased  1  3/6 (50.00%)  3/6 (50.00%)  14/131 (10.69%)  14/129 (10.85%) 
Blood alkaline phosphatase increased  1  3/6 (50.00%)  3/6 (50.00%)  10/131 (7.63%)  7/129 (5.43%) 
Blood albumin decreased  1  2/6 (33.33%)  0/6 (0.00%)  6/131 (4.58%)  2/129 (1.55%) 
Blood chloride decreased  1  2/6 (33.33%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Blood urine present  1  2/6 (33.33%)  0/6 (0.00%)  2/131 (1.53%)  2/129 (1.55%) 
Gamma-glutamyltransferase increased  1  2/6 (33.33%)  0/6 (0.00%)  2/131 (1.53%)  0/129 (0.00%) 
Blood amylase increased  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Blood calcium decreased  1  1/6 (16.67%)  0/6 (0.00%)  3/131 (2.29%)  2/129 (1.55%) 
Blood creatinine increased  1  1/6 (16.67%)  0/6 (0.00%)  5/131 (3.82%)  1/129 (0.78%) 
Blood potassium decreased  1  1/6 (16.67%)  1/6 (16.67%)  7/131 (5.34%)  0/129 (0.00%) 
Blood urea increased  1  1/6 (16.67%)  0/6 (0.00%)  3/131 (2.29%)  0/129 (0.00%) 
Glucose urine present  1  1/6 (16.67%)  1/6 (16.67%)  2/131 (1.53%)  3/129 (2.33%) 
Monocyte count decreased  1  1/6 (16.67%)  0/6 (0.00%)  2/131 (1.53%)  1/129 (0.78%) 
Platelet count increased  1  1/6 (16.67%)  1/6 (16.67%)  2/131 (1.53%)  0/129 (0.00%) 
Protein urine present  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Specific gravity urine decreased  1  1/6 (16.67%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Weight decreased  1  1/6 (16.67%)  2/6 (33.33%)  49/131 (37.40%)  29/129 (22.48%) 
Haemoglobin decreased  1  0/6 (0.00%)  2/6 (33.33%)  20/131 (15.27%)  19/129 (14.73%) 
Blood bilirubin increased  1  0/6 (0.00%)  1/6 (16.67%)  6/131 (4.58%)  7/129 (5.43%) 
Blood chloride increased  1  0/6 (0.00%)  1/6 (16.67%)  1/131 (0.76%)  0/129 (0.00%) 
White blood cell count decreased  1  0/6 (0.00%)  1/6 (16.67%)  28/131 (21.37%)  25/129 (19.38%) 
Neutrophil count decreased  1  0/6 (0.00%)  0/6 (0.00%)  23/131 (17.56%)  18/129 (13.95%) 
Metabolism and nutrition disorders         
Decreased appetite  1  4/6 (66.67%)  2/6 (33.33%)  80/131 (61.07%)  41/129 (31.78%) 
Hypoalbuminaemia  1  3/6 (50.00%)  2/6 (33.33%)  10/131 (7.63%)  5/129 (3.88%) 
Hypoproteinaemia  1  2/6 (33.33%)  1/6 (16.67%)  3/131 (2.29%)  3/129 (2.33%) 
Hypokalaemia  1  1/6 (16.67%)  0/6 (0.00%)  9/131 (6.87%)  7/129 (5.43%) 
Hyponatraemia  1  1/6 (16.67%)  0/6 (0.00%)  3/131 (2.29%)  0/129 (0.00%) 
Hyperglycaemia  1  0/6 (0.00%)  2/6 (33.33%)  3/131 (2.29%)  5/129 (3.88%) 
Abnormal loss of weight  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Hyperuricaemia  1  0/6 (0.00%)  1/6 (16.67%)  6/131 (4.58%)  2/129 (1.55%) 
Hypocalcaemia  1  0/6 (0.00%)  1/6 (16.67%)  3/131 (2.29%)  3/129 (2.33%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  3/6 (50.00%)  0/6 (0.00%)  21/131 (16.03%)  22/129 (17.05%) 
Muscle spasms  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  1/129 (0.78%) 
Arthralgia  1  0/6 (0.00%)  1/6 (16.67%)  16/131 (12.21%)  15/129 (11.63%) 
Back pain  1  0/6 (0.00%)  1/6 (16.67%)  14/131 (10.69%)  13/129 (10.08%) 
Nervous system disorders         
Dysgeusia  1  2/6 (33.33%)  3/6 (50.00%)  15/131 (11.45%)  5/129 (3.88%) 
Headache  1  2/6 (33.33%)  1/6 (16.67%)  9/131 (6.87%)  4/129 (3.10%) 
Hypoaesthesia  1  2/6 (33.33%)  0/6 (0.00%)  13/131 (9.92%)  7/129 (5.43%) 
Neuropathy peripheral  1  2/6 (33.33%)  0/6 (0.00%)  19/131 (14.50%)  20/129 (15.50%) 
Myoclonus  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Peripheral sensory neuropathy  1  1/6 (16.67%)  3/6 (50.00%)  33/131 (25.19%)  28/129 (21.71%) 
Somnolence  1  1/6 (16.67%)  2/6 (33.33%)  3/131 (2.29%)  2/129 (1.55%) 
Dizziness  1  0/6 (0.00%)  1/6 (16.67%)  12/131 (9.16%)  8/129 (6.20%) 
Psychiatric disorders         
Insomnia  1  2/6 (33.33%)  3/6 (50.00%)  10/131 (7.63%)  8/129 (6.20%) 
Renal and urinary disorders         
Proteinuria  1  2/6 (33.33%)  0/6 (0.00%)  5/131 (3.82%)  2/129 (1.55%) 
Dysuria  1  1/6 (16.67%)  0/6 (0.00%)  2/131 (1.53%)  0/129 (0.00%) 
Hydronephrosis  1  1/6 (16.67%)  0/6 (0.00%)  0/131 (0.00%)  0/129 (0.00%) 
Urinary retention  1  0/6 (0.00%)  1/6 (16.67%)  1/131 (0.76%)  0/129 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/6 (16.67%)  0/6 (0.00%)  11/131 (8.40%)  10/129 (7.75%) 
Epistaxis  1  1/6 (16.67%)  1/6 (16.67%)  22/131 (16.79%)  3/129 (2.33%) 
Hiccups  1  1/6 (16.67%)  1/6 (16.67%)  9/131 (6.87%)  5/129 (3.88%) 
Oropharyngeal pain  1  1/6 (16.67%)  1/6 (16.67%)  7/131 (5.34%)  2/129 (1.55%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  5/6 (83.33%)  4/6 (66.67%)  88/131 (67.18%)  73/129 (56.59%) 
Rash  1  3/6 (50.00%)  3/6 (50.00%)  64/131 (48.85%)  19/129 (14.73%) 
Dry skin  1  2/6 (33.33%)  0/6 (0.00%)  12/131 (9.16%)  4/129 (3.10%) 
Nail disorder  1  2/6 (33.33%)  0/6 (0.00%)  15/131 (11.45%)  6/129 (4.65%) 
Pruritus  1  2/6 (33.33%)  2/6 (33.33%)  23/131 (17.56%)  11/129 (8.53%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/6 (16.67%)  0/6 (0.00%)  10/131 (7.63%)  3/129 (2.33%) 
Pigmentation disorder  1  1/6 (16.67%)  0/6 (0.00%)  3/131 (2.29%)  0/129 (0.00%) 
Skin fissures  1  1/6 (16.67%)  0/6 (0.00%)  1/131 (0.76%)  0/129 (0.00%) 
Skin hyperpigmentation  1  1/6 (16.67%)  0/6 (0.00%)  4/131 (3.05%)  0/129 (0.00%) 
Cold sweat  1  0/6 (0.00%)  1/6 (16.67%)  0/131 (0.00%)  0/129 (0.00%) 
Drug eruption  1  0/6 (0.00%)  1/6 (16.67%)  1/131 (0.76%)  0/129 (0.00%) 
Skin exfoliation  1  0/6 (0.00%)  1/6 (16.67%)  1/131 (0.76%)  0/129 (0.00%) 
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: NCT00486954     History of Changes
Other Study ID Numbers: 104578
First Submitted: June 13, 2007
First Posted: June 15, 2007
Results First Submitted: December 20, 2012
Results First Posted: February 7, 2013
Last Update Posted: June 20, 2013