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| ID | Type | Description | Link |
|---|---|---|---|
| LPS14954 | Other Identifier | Sanofi |
Not provided
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The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caprelsa (vandetanib) 300 mg | Experimental | Daily oral dose of Caprelsa (vandetanib) 300mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 (vandetanib) | Drug | oral once daily tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0. | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
Not provided
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 | San Francisco | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20065189 | Background | Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11. |
| Label | URL |
|---|---|
| CSR-D4200C00008.pdf | View source |
Not provided
40 patients were enrolled/screened to the study but only 30 patients were entered treatment/randomized.
First patient enrolled 12 November 2004, last patient enrolled 15 August 2006, cut off date 22 February 2008. 40 patients were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Caprelsa (Vandetanib) 300 mg | Daily oral dose of Caprelsa (vandetanib) 300mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Caprelsa (Vandetanib) 300 mg | Daily oral dose of Caprelsa (vandetanib) 300mg |
| 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 | Objective Response Rate | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0. | Posted | Number | Participants | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
|
|
Not provided
Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caprelsa (Vandetanib) 300 mg | Daily oral dose of Caprelsa (vandetanib) 300mg | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDra 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C452423 | vandetanib |
Not provided
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| Duration of Objective Response | Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days. | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
| Disease Control Rate | Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0. | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
| Biochemical Response Calcitonin (CTN) | A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline). | Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation |
| Symptomatic Response | Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR. | Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. |
| World Health Organisation (WHO) Performance Status | Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled) | Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. |
| New Haven |
| Connecticut |
| United States |
| Research Site | New York | New York | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Villejuif | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Progression Free Survival | Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. | Upper limit is a censored value | Posted | Median | Full Range | months | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
|
|
|
| Secondary | Duration of Objective Response | Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days. | Posted | Median | 95% Confidence Interval | days | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
|
|
|
| Secondary | Disease Control Rate | Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0. | Posted | Number | Participants | Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. |
|
|
|
| Secondary | Biochemical Response Calcitonin (CTN) | A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline). | Posted | Number | Participants | Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation |
|
|
|
| Secondary | Symptomatic Response | Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR. | Posted | Number | Participants | Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. |
|
|
|
| Secondary | World Health Organisation (WHO) Performance Status | Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled) | Posted | Number | Participants | Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. |
|
|
|
| 30 |
| 14 |
| 30 |
| 30 |
| 30 |
| Diarrhoea Haemorrhagic | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Large Intestine Perforation | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Death | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Abdominal Infection | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Diverticulitis Intestinal Haemorrhagic | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | Systematic Assessment |
|
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDra 20.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDra 20.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDra 20.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDra 20.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDra 20.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDra 20.0 | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDra 20.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDra 20.0 | Systematic Assessment |
|
| Visual Disturbance | Eye disorders | MedDra 20.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Chills | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Temperature Intolerance | General disorders | MedDra 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDra 20.0 | Systematic Assessment |
|
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Blood Urea Increased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Electrocardiogram Qt Prolonged | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Platelet Count Increased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Weight Increased | Investigations | MedDra 20.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDra 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDra 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDra 20.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDra 20.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDra 20.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDra 20.0 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDra 20.0 | Systematic Assessment |
|
| Menstruation Irregular | Reproductive system and breast disorders | MedDra 20.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Periorbital Oedema | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDra 20.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDra 20.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDra 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra 20.0 | 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.
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |