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This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) | Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100 | Randomisation until Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Arterial Blood Pressure (MAP) | Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline). | Randomisation until Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Oncology Medical Sciences Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Houston | Texas | United States | |||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cediranib 30 mg | Cediranib 30mg/Day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cediranib 30 mg | Cediranib 30mg/Day |
| 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 | Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) | Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100 | Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit. | Posted | Geometric Mean | 95% Confidence Interval | Percentage change in SUVmax | Randomisation until Day 22 |
|
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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 | Cediranib 30 mg | Cediranib 30mg/Day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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| Barcelona |
| Spain |
| Withdrawal by Subject |
|
| Condition worsened |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in Mean Arterial Blood Pressure (MAP) | Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline). | Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit. | Posted | Mean | 95% Confidence Interval | mmHg | Randomisation until Day 22 |
|
|
|
| 3 |
| 19 |
| 18 |
| 19 |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tongue Haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acquired Tracheo-Oesophageal Fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood Corticotrophin Increased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Weight Decreased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Increased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Decreased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin Decreased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Urine Colour Abnormal | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cervical Root Pain | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin Reaction | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |