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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-005096-42 | EudraCT Number |
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This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Differentially Expressed Genes Associated With Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5. | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
| Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5. | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
| Number of KRAS Mutation Participants Who Achieved Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5. | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | B-1200 | Belgium | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
| Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST | Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions. | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
| Sofia |
| 1756 |
| Bulgaria |
| Tallinn | 11619 | Estonia |
| Tartu | 51014 | Estonia |
| Montpellier | 34295 | France |
| Paris | 75970 | France |
| Cologne | 50937 | Germany |
| Großhansdorf | 22927 | Germany |
| Hong Kong | Hong Kong |
| Dublin | 8 | Ireland |
| Perugia | 06132 | Italy |
| Gdansk | 80-214 | Poland |
| Lodz | 94-306 | Poland |
| Lublin | 20-950 | Poland |
| Poznan | 60-569 | Poland |
| Moscow | 105229 | Russia |
| Moscow | 107005 | Russia |
| Moscow | 115478 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197758 | Russia |
| Saint Petersburg | 198255 | Russia |
| Singapore | 169610 | Singapore |
| Barcelona | 08035 | Spain |
| Barcelona | 08916 | Spain |
| Madrid | 28041 | Spain |
| Taipei | 00112 | Taiwan |
| Taipei | 105 | Taiwan |
| Taipei | 106 | Taiwan |
| Weston-super-Mare | BS23 4TQ | United Kingdom |
| Safety Analysis Population (SAP) |
|
| COMPLETED |
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| NOT COMPLETED |
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Analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Number of Differentially Expressed Genes Associated With Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5. | Primary analysis set (PAS) included all participants who provided evaluable tissue samples and were included in the primary Affymetrix efficacy analysis. | Posted | Number | genes | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5. | PAS participants who had EGFR mutation at baseline were included in this analysis. | Posted | Number | participants | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
|
| |||||||||||||||||||||||||||
| Primary | Number of KRAS Mutation Participants Who Achieved Clinical Benefit | Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5. | PAS participants who had KRAS mutation at baseline were included in this analysis. | Posted | Number | participants | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. | Analysis population included all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST | Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions. | Analysis population included all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years |
|
Up to 4 years
Safety analysis population (SAP) included all participants who received at least one dose of the trial medication and had a safety follow-up.
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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 | Erlotinib | Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death. | 65 | 261 | 209 | 261 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Skin ulcer haemorrhage | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Arterial haemorrhage | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Shock | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Units | Counts |
|---|
| Participants |
|
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