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This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib [Tarceva] | Drug | 150 mg orally daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (Tumour Assessments According to RECIST Criteria) | Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death. | Until participants had disease progression, unacceptable toxicity or died; approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Investigator Assessed) | Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plovdiv | 4004 | Bulgaria | ||||
In all 145 participants were screened, of these 6 participants were randomized; major reason for screen failure was negative mutation status.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months) |
| Safety: Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. |
| Overall Survival | The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause. | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. |
| Sofia |
| 1404 |
| Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Stara Zagora | 8000 | Bulgaria |
| Varna | 9002 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Progression-free Survival (Tumour Assessments According to RECIST Criteria) | Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death. | The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment. | Posted | Median | Inter-Quartile Range | Days | Until participants had disease progression, unacceptable toxicity or died; approximately 24 months. |
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| Secondary | Objective Response Rate (Investigator Assessed) | Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. | The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X). | Posted | Number | 95% Confidence Interval | Percentage | Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months) |
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| Secondary | Safety: Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study. | Posted | Number | participants | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. |
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| Secondary | Overall Survival | The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause. | The ITT population included all patients with at least one valid post-baseline assessment. | Posted | Median | Full Range | Days | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. |
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Upto 24 months
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
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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 | Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation. | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Orchitis | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Candidiasis (vulvovaginal) | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Parasternal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Forunculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.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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