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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003593-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zactima (vandetanib) | Drug | |||
| Docetaxel | Drug | |||
| Prednisolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Specific Antigen (PSA) Response | Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response | PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With an Objective 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 and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO) |
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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 | Rio de Janeiro | Brazil | ||||
| Research Site |
Not provided
First patient randomised 24 January 2006, last patient randomised 24 Nov 2006, data cut off data 21 July 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib | docetaxel/prednisolone/vandetanib |
| FG001 | Placebo | docetaxel/prednisolone/placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib | docetaxel/prednisolone/vandetanib |
| BG001 | Placebo | docetaxel/prednisolone/placebo |
| 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 | Prostate Specific Antigen (PSA) Response | Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response | Posted | Number | Participants | PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline |
|
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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 | docetaxel/prednisolone/vandetanib |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | 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 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000077143 | Docetaxel |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| São Paulo |
| Brazil |
| Research Site | Hamburg | Germany |
| Research Site | Hanover | Germany |
| Research Site | Kassel | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Umeå | Sweden |
| Research Site | Uppsala | Sweden |
| Condition under investigation worsened |
|
| Other |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients With an Objective 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 and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO) |
|
|
|
| 23 |
| 43 |
| 38 |
| 43 |
| EG001 | Placebo | docetaxel/prednisolone/placebo | 15 | 43 | 39 | 43 |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| BLINDNESS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| LOBAR PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| STERNAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| TOXIC SKIN ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac 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 |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DYSPEPSIA | 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 |
|
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system 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 |
|
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| ONYCHOMADESIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| RASH PAPULAR | 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 |
|
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.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |