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| ID | Type | Description | Link |
|---|---|---|---|
| CLAP016A2202 | Other Identifier | Novartis | |
| 2005-003944-68 | EudraCT Number |
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Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | 750 mg lapatinib administered orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | tyrosine kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Central Nervous System (CNS) Best Overall Response | Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR) | Summary of CNS Objective Response (the Complete Response + Partial Response) | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet | Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Francisco | California | 94115 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20179708 | Result | Sutherland S, Ashley S, Miles D, Chan S, Wardley A, Davidson N, Bhatti R, Shehata M, Nouras H, Camburn T, Johnston SR. Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases--the UK experience. Br J Cancer. 2010 Mar 16;102(6):995-1002. doi: 10.1038/sj.bjc.6605586. Epub 2010 Feb 23. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Main phase: ITT 95 in Cohort A, 147 in Cohort B. MITT, 94 in Cohort A, and 143 subjects in Cohort B Optional open-label extension phase: 51 subjects. Long-term follow up (LTFU) Protocol amendment added on 15-Apr-2013
The Intent-to-Treat (ITT) Population: all subjects who received at least one dose of study medication
Modified ITT (MITT) Population: all subjects who received at least four doses (750 mg lapatinib twice daily for two days) of study medication and who had measurable brain metastases (≥1 cm in diameter) at baseline assessment
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS) | Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS | baseline and weeks 8, 16, 24, 32, 40, 48 |
| Duration of Central Nervous System (CNS) Objective Response | The duration of CNS objective response, defined as the time from first CNS Objective response until tumor progression at any site or death due to any cause. A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms. | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy | The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24 | from Start of lapatinib to 6 months |
| Time to Progression (TTP) at Any Site | Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Overall Survival (OS) | Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause. | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Summary of Site of First Progression | baseline to time of disease progression or death | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Primary Cause of Death | Summary of Overall All-cause mortality (Main Study and Extension) | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| Vallejo |
| California |
| 94589 |
| United States |
| Novartis Investigative Site | Denver | Colorado | 80220 | United States |
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20007 | United States |
| Novartis Investigative Site | Boca Raton | Florida | 33428 | United States |
| Novartis Investigative Site | Jacksonville | Florida | 32224 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46227 | United States |
| Novartis Investigative Site | Sioux City | Iowa | 51101-1733 | United States |
| Novartis Investigative Site | Kansas City | Kansas | 66160 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110-1093 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87106 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87108 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87131-0001 | United States |
| Novartis Investigative Site | Santa Fe | New Mexico | 87505 | United States |
| Novartis Investigative Site | New York | New York | 10021 | United States |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Tyler | Texas | 75702 | United States |
| Novartis Investigative Site | Seattle | Washington | 98109 | United States |
| Novartis Investigative Site | Yakima | Washington | 98902 | United States |
| Novartis Investigative Site | North Sydney | New South Wales | 2060 | Australia |
| Novartis Investigative Site | Herston | Queensland | 4029 | Australia |
| Novartis Investigative Site | South Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Box Hill | Victoria | 3128 | Australia |
| Novartis Investigative Site | Ringwood East | Victoria | 3135 | Australia |
| Novartis Investigative Site | Perth | Western Australia | 6000 | Australia |
| Novartis Investigative Site | Adelaide | 5000 | Australia |
| Novartis Investigative Site | Salzburg | A-5020 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5B 1W8 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Weston | Ontario | M9N 1N8 | Canada |
| Novartis Investigative Site | Dijon | 21079 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Paris | 75248 | France |
| Novartis Investigative Site | Toulouse | 31052 | France |
| Novartis Investigative Site | Munich | Bavaria | 80637 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 81377 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Neo Faliro | 18547 | Greece |
| Novartis Investigative Site | Bangalore | 560078 | India |
| Novartis Investigative Site | Mumbai | 400026 | India |
| Novartis Investigative Site | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Novartis Investigative Site | Milan | Lombardy | 20141 | Italy |
| Novartis Investigative Site | Perugia | Umbria | 06156 | Italy |
| Novartis Investigative Site | Aichi | 464-8681 | Japan |
| Novartis Investigative Site | Saitama | 350-0495 | Japan |
| Novartis Investigative Site | Saitama | 350-1298 | Japan |
| Novartis Investigative Site | Tokyo | 104-0045 | Japan |
| Novartis Investigative Site | Tokyo | 113-8677 | Japan |
| Novartis Investigative Site | Tokyo | 135-8550 | Japan |
| Novartis Investigative Site | Olsztyn | 10-228 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Uppsala | SE-751 85 | Sweden |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| Novartis Investigative Site | Locarno | 6600 | Switzerland |
| Novartis Investigative Site | Tainan County | 736 | Taiwan |
| Novartis Investigative Site | Taipei | 10016 | Taiwan |
| Novartis Investigative Site | Taipei | 114 | Taiwan |
| Novartis Investigative Site | Manchester | Lancashire | M20 4BX | United Kingdom |
| Novartis Investigative Site | Brighton | BN2 5BE | United Kingdom |
| Cohort B |
750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohorts A | Overall - Main Study and Extension Phase - 750 mg lapatinib administered orally twice daily Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings. |
| BG001 | Cohort B | 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Lapatinib Monotherapy - ITT Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Central Nervous System (CNS) Best Overall Response | Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms | Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm. | Posted | Count of Participants | Participants | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR) | Summary of CNS Objective Response (the Complete Response + Partial Response) | Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm. | Posted | Number | 95% Confidence Interval | percentage of participants | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet | Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive. | MITT population Analysis was performed on combined cohorts in order to have a sufficient sample size to analyze association of CNS Volumetric Change from Baseline and NSS Improvement | Posted | Count of Participants | Participants | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS) | Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS | MITT | Posted | Number | 95% Confidence Interval | percentage of participants | baseline and weeks 8, 16, 24, 32, 40, 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Central Nervous System (CNS) Objective Response | The duration of CNS objective response, defined as the time from first CNS Objective response until tumor progression at any site or death due to any cause. A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms. | Lapatinib monotherapy MITT | Posted | Median | 95% Confidence Interval | months | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy | The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24 | MITT | Posted | Number | 95% Confidence Interval | percentage of participants | from Start of lapatinib to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) at Any Site | Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site | Lapatinib Monotherapy MITT | Posted | Median | 95% Confidence Interval | months | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause. | Lapatinib Monotherapy MITT | Posted | Median | 95% Confidence Interval | months | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
|
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| Secondary | Summary of Site of First Progression | baseline to time of disease progression or death | MITT | Posted | Count of Participants | Participants | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Primary Cause of Death | Summary of Overall All-cause mortality (Main Study and Extension) | ITT | Posted | Count of Participants | Participants | time from baseline to data cutoff (25 Sept 2007); approximately 2 years |
|
|
AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months.
All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from FPFV until LPLV up to a maximum of 12 years and 3 months
SAEs are presented from main and extension phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EGF105084/Cohort A | Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings | 78 | 95 | 36 | 95 | 90 | 95 |
| EG001 | EGF105084/Cohort B | Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings | 128 | 147 | 52 | 147 | 131 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| On treatment deaths | General disorders | MedDRA (20.1) | Systematic Assessment | All participants who died while on treatment of all disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
Outcome Quantitative Toxicities Associated with Oral Lapatinib are in Adverse Events section. No analysis was performed for 2 outcomes: Relationship of PET Uptake, as Predictors of Response; and Relationship Between Genetic Variants in Select Genes
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e.; data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 (862) 778-8300 | novartis.email@novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 18-64 years |
|
| 65-84 years |
|
| >85 years |
|
| Male |
|
| American Indian/Alaskan Native |
|
| Asian - Central/South |
|
| Asian - Japanese |
|
| Asian - South-East Asian |
|
| Asia - East |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic/North African |
|
| White - White/ Caucasian/European |
|
| Mixed race |
|
| Unknown |
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Unknown |
|
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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