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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002168-26 | EudraCT Number |
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This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib [Tarceva] | Drug | 150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology. | Baseline to progressive disease or death (up to 34 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response (BOR) | BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. 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 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 |
|---|---|---|---|---|---|---|
| Budapest | 1125 | Hungary | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29801465 | Derived | Markoczy Z, Sarosi V, Kudaba I, Galffy G, Turay UY, Demirkazik A, Purkalne G, Somfay A, Papai-Szekely Z, Raso E, Ostoros G. Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial. BMC Cancer. 2018 May 25;18(1):598. doi: 10.1186/s12885-018-4283-z. |
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A total of 651 participants were screened and among them 62 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib Hydrochloride | Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to progressive disease or death (up to 34 months) |
| Percentage of Participants Who Were Alive at 1 Year | 1 Year (12 months) |
| Budapest |
| 1529 |
| Hungary |
| Debrecen | 4032 | Hungary |
| Deszk | 6772 | Hungary |
| Farkasgyepű | 8582 | Hungary |
| Gyula | 5703 | Hungary |
| Mátraháza | 3233 | Hungary |
| Mosonmagyaróvar | 9200 | Hungary |
| NyÃregyháza | 4400 | Hungary |
| Pécs | 7623 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8001 | Hungary |
| Szolnok | 5004 | Hungary |
| Szombathely | 9700 | Hungary |
| Törökbálint | 2045 | Hungary |
| Törökbálint | H-2045 | Hungary |
| Riga | LV 1079 | Latvia |
| Riga | LV-1002 | Latvia |
| Ankara | 06230 | Turkey (Türkiye) |
| Ankara | 06280 | Turkey (Türkiye) |
| Antalya | 07070 | Turkey (Türkiye) |
| Edirne | 22030 | Turkey (Türkiye) |
| Istanbul | 34890 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib Hydrochloride | Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months. |
| 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 |
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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 (PFS) | PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology. | ITT population. | Posted | Median | 95% Confidence Interval | Months | Baseline to progressive disease or death (up to 34 months) |
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| Secondary | Percentage of Participants With Best Overall Response (BOR) | BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. 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 study. | ITT population. | Posted | Number | Percentage of Participants | Baseline to progressive disease or death (up to 34 months) |
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| Secondary | Percentage of Participants Who Were Alive at 1 Year | ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome. | Posted | Number | Percentage of Participants | 1 Year (12 months) |
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Baseline up to 28 days after the last dose of study medication (up to 34 months)
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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 Hydrochloride | Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months. | 26 | 62 | 49 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Ileus Paralytic | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Sudden Cardiac Death | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Liver Injury | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Liver Function Test Abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Infected Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Balance Disorder | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rash Generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Growth of Eyelashes | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-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 | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 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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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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