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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2005-003442-33 |
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The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 30 mg AZD2171 |
|
| 2 | Experimental | 45 mg AZD2171 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | 30 mg & 45 mg oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 | 12 week treatment period | |
| Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171 | Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression) | 12 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171 | First 6 weeks of 12 week treatment period | |
| Objective Response Rate | Number of patients with complete or partial response (CR/PR), based on RECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Freiburg im Breisgau | Germany | ||||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2171 30 mg Anti HT | AZD2171 30 mg AntiHT prophylaxis |
| FG001 | AZD2171 30 mg No Anti HT | AZD2171 30 mg No AntiHT prophylaxis |
| FG002 | AZD2171 45 mg Anti HT | AZD2171 45 mg AntiHT prophylaxis |
| FG003 | AZD2171 45 mg No Anti HT | AZD2171 45 mg No AntiHT prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2171 30 mg Anti HT | AZD2171 30 mg AntiHT prophylaxis |
| BG001 | AZD2171 30 mg No Anti HT | AZD2171 30 mg No AntiHT prophylaxis |
| 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 | Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 | Posted | Number | Participants | 12 week treatment period |
|
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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 | AZD2171 30 mg Anti HT | AZD2171 30 mg AntiHT prophylaxis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Ischaemia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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| 12 week treatment period |
| Best Percentage Change in Tumour Size | Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size. | Randomisation until end of treatment period |
| Hamburg |
| Germany |
| Research Site | Amsterdam | Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | Utrecht | Netherlands |
| Research Site | Surrey | United Kingdom |
| Withdrawal by Subject |
|
| Other |
|
| Development study specific disc. crit. |
|
| Cond. under inv. worsened |
|
| Not treated |
|
| BG002 | AZD2171 45 mg Anti HT | AZD2171 45 mg AntiHT prophylaxis |
| BG003 | AZD2171 45 mg No Anti HT | AZD2171 45 mg No AntiHT prophylaxis |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 |
| AZD2171 45 mg No Anti HT |
AZD2171 45 mg No AntiHT prophylaxis |
|
|
| Primary | Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171 | Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression) | Posted | Median | 90% Confidence Interval | Poportion of Planned Dose | 12 week treatment period |
|
|
|
| Secondary | Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171 | Posted | Number | Participants | First 6 weeks of 12 week treatment period |
|
|
|
| Secondary | Objective Response Rate | Number of patients with complete or partial response (CR/PR), based on RECIST | Posted | Number | Participants | 12 week treatment period |
|
|
|
| Secondary | Best Percentage Change in Tumour Size | Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size. | Posted | Geometric Mean | 90% Confidence Interval | percentage of tumor size | Randomisation until end of treatment period |
|
|
|
| 19 |
| 28 |
| 31 |
| 28 |
| EG001 | AZD2171 30 mg No Anti HT | AZD2171 30 mg No AntiHT prophylaxis | 20 | 31 | 34 | 31 |
| EG002 | AZD2171 45 mg Anti HT | AZD2171 45 mg AntiHT prophylaxis | 10 | 26 | 27 | 26 |
| EG003 | AZD2171 45 mg No Anti HT | AZD2171 45 mg No AntiHT prophylaxis | 10 | 34 | 26 | 34 |
| Sinus Tachycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Large Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Euthanasia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Infected Skin Ulcer | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Bilirubin Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Hepatic Enzyme Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhage Intracranial | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Urethral Pain | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Venous Thrombosis Limb | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
|
| Ear Discomfort | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Temperature Intolerance | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Rash Pustular | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Weight Decreased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Bilirubin Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Creatinine Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Transaminases Increased | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.1 | 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.