Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gemcitabine + Carboplatin |
|
| 2 | Experimental | Gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression | Date of randomization to earliest date of objective disease progression |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Canada Oncology Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Montreal | Quebec | Canada |
Following enrolment there was a 7 - 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.
Following objective disease progression on randomized treatment (Period 1), subjects were encouraged to crossover to the other treatment (Period 2).
Patients were recruited at 2 Canadian cancer clinics between October 2004 and October 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator | Gemcitabine + Carboplatin |
| FG001 | Experimental | Gefitinib |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Treatment |
|
| |||||||||||||||||||||
| Crossover Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | Gemcitabine + Carboplatin |
| BG001 | Experimental | Gefitinib |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression | Posted | Mean | 95% Confidence Interval | Days | Date of randomization to earliest date of objective disease progression |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator | Gemcitabine + Carboplatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
No analysis of the efficacy results was performed as the study was prematurely terminated with only 35 out of the planned 122 subjects randomized.
Serious and Other adverse event data for Periods 1 and 2 were combined by treatment for this report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | intravenous injection |
|
|
| Carboplatin | Drug | intravenous injection |
|
|
| Objective disease Progression |
|
| Physician Decision |
|
| Incorrectly randomized |
|
| Study Closure |
|
| Protocol Violation |
|
| NOT COMPLETED |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Participants |
|
|
| 4 |
| 23 |
| EG001 | Experimental | Gefitinib | 4 | 26 |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fatigue | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Asthenia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Chest pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Catheter site pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pitting oedema | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Weight decreased | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |