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This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | 150 mg erlotinib daily |
|
| Erlotinib + chemotherapy (intercalated) | Experimental | carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarceva | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression-free Survival | Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | 6 months after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | Until time of disease progression, as assessed every 21 days (maximum 28.8 months) |
| Overall Survival at 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hematology Oncology Medical Group Inc. | Alhambra | California | 91801 | United States | ||
| Comprehensive Blood and Cancer Center(Part of TORI network) |
Not provided
| Label | URL |
|---|---|
| OSI Pharmaceuticals website | View source |
Not provided
All enrolled patients were randomly assigned to 1 of 2 treatment groups.
The first patient was treated 28 March 2006 and the analysis database locked 20 March 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | 150 mg erlotinib daily |
| FG001 | Erlotinib + Chemotherapy (Intercalated) | carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| carboplatin | Drug | IV |
|
| paclitaxel | Drug | IV |
|
Percentage of patients alive after 12 months of study treatment |
| 12 months from 1st dose |
| Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death (maximum 29.0 months) |
| Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months) |
| Duration of Tumor Response | Median length of time that tumor showed any type of response, ie, CR, PR, or SD | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). |
| Bakersfield |
| California |
| 93309 |
| United States |
| Bay Area Cancer Research Group | Concord | California | 94520 | United States |
| Virginia K. Crosson Cancer Center | Fullerton | California | 92835 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813-3244 | United States |
| UCLA Medical Center | Los Angeles | California | 90095-7077 | United States |
| North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center | Northridge | California | 91325 | United States |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | United States |
| Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center | Pomona | California | 91767 | United States |
| Cancer Care Associates Medical Group, Inc. | Redondo Beach | California | 90277 | United States |
| Sansum Santa Barbara Medical Foundation Clinic | Santa Barbara | California | 93105 | United States |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer CenterResearch Department | Denver | Colorado | 80218 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360-2910 | United States |
| MD Anderson Cancer Ctr - Orlando | Orlando | Florida | 32806 | United States |
| Gulfcoast Oncology Associates | Tampa | Florida | 33614 | United States |
| Suburban Hematology-Oncology Associates | Lawrenceville | Georgia | 30045 | United States |
| Central Georgia Cancer Care, P.C. | Macon | Georgia | 31201 | United States |
| Rush-Presbyterian-St.Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Norton Healthcare, Inc. | Louisville | Kentucky | 40202 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Univ. of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Hematology Oncology Centers of Northern Rockies Research | Billings | Montana | 59101 | United States |
| Alegent Healthcare | Omaha | Nebraska | 68124 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| Hematology-Oncology Associates, SJ, PA - Virtua Health | Mount Holly | New Jersey | 08060 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Pottsville Cancer Clinic | Pottsville | Pennsylvania | 17901 | United States |
| Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst. | Memphis | Tennessee | 38104 | United States |
| The West Cancer Clinic | Memphis | Tennessee | 38120 | United States |
| ACORN | Memphis | Tennessee | 38138 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| Cancer Specialists of Tidewater, Ltd. | Chesapeake | Virginia | 23320 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| CR UK | Cambridge | CB2 2RE | United Kingdom |
| Peterborough District Hospital | Cambridge | PE3 6DA | United Kingdom |
| Beatson Oncology Centre | Glasgow | G11 6NT | United Kingdom |
| Mount Vernon Hospital | Middlesex | HA6 2RN | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | 150 mg erlotinib daily |
| BG001 | Erlotinib + Chemotherapy (Intercalated) | carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | 6-month Progression-free Survival | Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | All patients who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Patients | 6 months after first dose |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | All patients who received at least 1 dose of study drug | Posted | Median | Full Range | months | Until time of disease progression, as assessed every 21 days (maximum 28.8 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival at 12 Months | Percentage of patients alive after 12 months of study treatment | All patients who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Percent of Patients | 12 months from 1st dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Median number of months from first study treatment until time of death | All patients who received at least 1 dose of study drug | Posted | Median | Full Range | Months | From first study treatment until time of death (maximum 29.0 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline | All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment | Posted | Number | Percent of Patients | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Tumor Response | Median length of time that tumor showed any type of response, ie, CR, PR, or SD | All patients who had any type of tumor response, ie, CR, PR, or SD | Posted | Median | Full Range | Months | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). |
|
|
While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug
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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 | 150 mg erlotinib daily | 27 | 69 | 67 | 69 | ||
| EG001 | Erlotinib + Chemotherapy (Intercalated) | carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity | 27 | 68 | 67 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Epistaxix | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombophlebitis superfical | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Spinal chord compression | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemorrhagic arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment | Pooled skin event terms |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
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| Black |
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| Asian |
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| Hispanic |
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| Other |
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