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The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | Gefitinib tablet 250mg once daily orally |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
| Measure | Description | Time Frame |
|---|---|---|
| Period of Progression-Free Survival | The median months without event of progression disease according to RECIST criteria is analysed. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
| Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Daegu | South Korea |
The subjects were able to provide sample of EGFR mutation test and the subjects who had positive EGFR results or satisfy more than two condition of adenocarcinoma, female or non smoker were eligible.
From January 2007 to July 2008, 156 subjects were enrolled from 11 centers in Korea. First subject in date: 17 January 2007. Last subject last visit(Data cut off) date: 2 January 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefitinib | gefitinib tablet 250 mg orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefitinib | gefitinib tablet 250 mg orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Objective Response Rate(ORR) | Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Posted | Number | Percent of participants | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
|
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An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
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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 | Gefitinib | gefitinib tablet 250 mg orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hui Jung Sin | Medical, Astrazeneca Korea | huijung.sin@astrazeneca.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28. The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L. The percentage of patients who showed improvement is reported. |
| Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
| Overall Survival | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. |
| Adverse Event | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
| Adverse Event |
|
| Physician Decision |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| EGFR mutation status | Epidermal growth factor receptor (EGFR) mutation analysis, PCR test on exon 18, 19 and 21 of EGFR gene was used. | Number | Participants |
|
| Smoking history | Number | Participants |
|
| Tumour history | Number | Participants |
|
| World Health Organisation (WHO) Performance Status | WHO has 5 grades (0-4), 0 -Fully active, 1-Restricted in strenuous activity, 2- Ambulatory and capable of all self-care, 3-Capable of only limited self-care and 4- Completely disabled. | Number | Participants |
|
| Disease Stage | The tumor node metastasis (TNM) staging system (NSCLC) was used to determine the disease stage. Stage is usually expressed as a number on a scale of 0 through IV - with stage 0 describing non-invasive cancers that remain within their original location and stage IV describing invasive cancers that have spread outside to other parts of the body. Number of patients with different disease stage is reported. | Number | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Period of Progression-Free Survival | The median months without event of progression disease according to RECIST criteria is analysed. | Posted | Median | 95% Confidence Interval | months | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
|
|
|
| Secondary | Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L) | Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28. The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L. The percentage of patients who showed improvement is reported. | Posted | Number | percentage of participants | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
|
|
|
| Secondary | Overall Survival | Not Posted | Number | month | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death. |
| Secondary | Adverse Event | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. | Posted | Number | participants | Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) |
|
|
|
| 25 |
| 154 |
| 141 |
| 154 |
| Pericardial effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Death | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Multi-organ failure | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sudden death | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |