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This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lapatinb | Experimental | Lapatinib 1500mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | Lapatinib 1500mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tumor Response | Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria. | Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer. | First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. |
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Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
Patients with ErbB2 overexpression:
Neutrophil count ≥1500 /mm3 Hemoglobin ≥9 g/dL (at least 2 weeks after blood transfusion if needed) Platelet count ≥100,000 /mm3
Albumin ≤2.5 g/dL Total bilirubin ≤1.5xULN AST, ALT: ≤3xULN (without liver metastases), ≤5xULN (if documented liver metastases)
Serum creatinine ≤1.5 mg/dL, or creatinine clearance ≤40 mL/min (calculated by the Cockcroft and Gault Method)
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ehime | 791-0280 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19844234 | Background | Toi M, Iwata H, Fujiwara Y, Ito Y, Nakamura S, Tokuda Y, Taguchi T, Rai Y, Aogi K, Arai T, Watanabe J, Wakamatsu T, Katsura K, Ellis CE, Gagnon RC, Allen KE, Sasaki Y, Takashima S. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer. 2009 Nov 17;101(10):1676-82. doi: 10.1038/sj.bjc.6605343. Epub 2009 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lapatinib Monotherapy | Lapatinib: 1500 mg (six 250 mg tablets) orally once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lapatinib Monotherapy | Lapatinib: 1500 mg (six 250 mg tablets) orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Tumor Response | Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria. | Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product | Posted | Number | participants | Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. |
|
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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 | Lapatinib Monotherapy | Lapatinib: 1500 mg (six 250 mg tablets) orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Time to Progression | Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions. | Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death. |
| Clinical Benefit | Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks. | Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death. |
| Time to Response | Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first). | Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death. |
| 4-month Progression Free Survival | The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing. | Baseline to Month 4 (Week 16) |
| 6-month Progression Free Survival | The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing. | Baseline to Month 6 (Week 24) |
| Overall Survival | Overall survival was measured as the time between the start of dosing until death, regardless of cause. | Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death. |
| Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants | Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean p-BAD H Score for All Participants | Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Bcl-2 H Score for All Participants | Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants | Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants | Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants | Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Heregulin H Score for All Participants | Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants | Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Survivin H Score for All Participants | Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants | Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Tumor samples taken at baseline |
| Fukuoka |
| 814-0180 |
| Japan |
| GSK Investigational Site | Kanagawa | 241-0815 | Japan |
| GSK Investigational Site | Okayama | 701-0192 | Japan |
| GSK Investigational Site | Tochigi | 329-0498 | Japan |
| GSK Investigational Site | Tokyo | 104-0045 | Japan |
| GSK Investigational Site | Tokyo | 113-8677 | Japan |
| GSK Investigational Site | Tokyo | 135-8550 | Japan |
| GSK Investigational Site |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Lapatinib: 1500 mg (six 250 mg tablets) orally once daily |
|
|
| Secondary | Duration of Response | Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer. | Participants who achieved defined efficacy | Posted | Median | Inter-Quartile Range | weeks | First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. |
|
|
|
| Secondary | Time to Progression | Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions. | ITT Population | Posted | Median | Inter-Quartile Range | weeks | Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death. |
|
|
|
| Secondary | Clinical Benefit | Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks. | ITT Population | Posted | Number | percentage of participants | Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death. |
|
|
|
|
| Secondary | Time to Response | Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first). | Participants in the ITT Population achieving a partial or complete response | Posted | Median | Full Range | Days | Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death. |
|
|
|
| Secondary | 4-month Progression Free Survival | The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing. | ITT Population | Posted | Number | percentage of participants | Baseline to Month 4 (Week 16) |
|
|
|
|
| Secondary | 6-month Progression Free Survival | The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing. | ITT Population | Posted | Number | percentage of participants | Baseline to Month 6 (Week 24) |
|
|
|
|
| Secondary | Overall Survival | Overall survival was measured as the time between the start of dosing until death, regardless of cause. | ITT Population | Posted | Median | Inter-Quartile Range | weeks | Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death. |
|
|
|
| Secondary | Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants | Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation. | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean p-BAD H Score for All Participants | Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Bcl-2 H Score for All Participants | Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants | Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants | Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants | Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Heregulin H Score for All Participants | Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants | Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Survivin H Score for All Participants | Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| Secondary | Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants | Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression. | Participants who provided enough tumor samples for this evaluation | Posted | Mean | Standard Deviation | units on a scale | Tumor samples taken at baseline |
|
|
|
| 14 |
| 58 |
| 58 |
| 58 |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ventricular dysfunction | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Comedone | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Generalized erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Asteatotic eczema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hair disorder | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Eye lid infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Localized infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Omphalitis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Edema | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Eosinophil count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Protein urine | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Specific gravity urine | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hypoesthesia | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Cystitis-like symptom | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Eyelid edema | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Scleral hemorrhage | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Conjunctival hyperemia | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vasodilatation | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (8.1) | Systematic Assessment |
|
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| Brachial plexus injury | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Hypersensitivity | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
|
| Genital hemorrhage | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
|
| Breast discharge | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (8.1) | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA (8.1) | Systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |