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| ID | Type | Description | Link |
|---|---|---|---|
| D7913L00008 |
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The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib (ZD1839) | Experimental | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
| Number of Serious Adverse Events (SAEs) Related to ZD1839 | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
| Number of Other Adverse Events (AEs) | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
| Number of Other Adverse Events (AEs) Related to ZD1839 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Germany Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Freiburg im Breisgau | Germany | ||||
| Research Site |
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First subject enrolled: 16 June 2005, Last subject last visit: 18 May 2015. The study was conducted in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefitinib (ZD1839) | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefitinib (ZD1839) | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
| 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 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Progression-free Survival (PFS) | Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | Months | From randomization until progression or death (up to 120 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 | Gefitinib (ZD1839) | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
The study was stopped after enrolling 14 of 100 patients. The outcome was biased by the limited number of patients. Therefore, data allow only a limited statement on efficacy and long term safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | 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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Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. |
| Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
| From randomization until progression or death (up to 120 months) |
| Overall Survival (OS) | From randomization until death (up to 120 months) |
| Gauting |
| Germany |
| Research Site | Großhansdorf | Germany |
| Research Site | Hemer | Germany |
| Research Site | Jena | Germany |
| Research Site | Minden | Germany |
| Research Site | Tübingen | Germany |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival (OS) | Posted | Median | 95% Confidence Interval | Months | From randomization until death (up to 120 months) |
|
|
|
| Primary | Number of Serious Adverse Events (SAEs) | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease | Posted | Number | number of SAEs | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
|
|
|
| Primary | Number of Serious Adverse Events (SAEs) Related to ZD1839 | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. | Posted | Number | Number of SAEs related to ZD1839 | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
|
|
|
| Primary | Number of Other Adverse Events (AEs) | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. | Posted | Number | number of other AEs | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
|
|
|
| Primary | Number of Other Adverse Events (AEs) Related to ZD1839 | Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease. | Posted | Number | number of other AEs related to ZD1839 | Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) |
|
|
|
| 4 |
| 14 |
| 11 |
| 14 |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Bronchopneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| Death | General disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
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| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
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| Haematemesis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
|
| General physical health deterioration | General disorders | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment | Causality to study medication: No |
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| DIZZINESS | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| EPIDIDYMITIS | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 19.0 | Systematic Assessment |
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| GALLBLADDER PAIN | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| OEDEMA | General disorders | MedDRA 19.0 | Systematic Assessment |
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| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| PARONYCHIA | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| RECTAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |