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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003592-20 | EudraCT Number |
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To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Docetaxel + placebo vandetanib |
|
| 2 | Experimental | Vandetanib + Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vandetanib (ZD6474) | Drug | once daily oral dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Disease Progression Event | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) | RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Budapest | Hungary | ||||
| Research Site |
Not provided
First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib Plus Docetaxel | vandetanib 100 mg plus docetaxel |
| FG001 | Placebo Plus Docetaxel | placebo plus docetaxel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib Plus Docetaxel | vandetanib 100 mg plus docetaxel |
| BG001 | Placebo Plus Docetaxel | placebo plus docetaxel |
| 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 | Number of Patients With a Disease Progression Event | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) | Posted | Number | Participants | RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off |
|
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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 | Vandetanib Plus Docetaxel | vandetanib 100 mg plus docetaxel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | intravenous infusion |
|
|
| Pécs |
| Hungary |
| Research SIte | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Observatory | South Africa |
| Research Site | Barakaldo | Spain |
| Research SIte | Lleida | Spain |
| Research Site | Zaragoza | Spain |
| Research Site | Umeå | Sweden |
| Research Site | Uppsala | Sweden |
| Research Site | Västerås | Sweden |
| Research Site | Taipei | Taiwan |
| Other |
|
| Never received IP |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 14 |
| 33 |
| 33 |
| 33 |
| EG001 | Placebo Plus Docetaxel | placebo plus docetaxel | 12 | 29 | 25 | 29 |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenic Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vocal Cord Paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis Exfoliative | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Toxic Epidermal Necrolysis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Performance Status Decreased | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Chemical Eye Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Weight Decreased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nail Discolouration | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nail Pigmentation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |