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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001354-28 | EudraCT Number |
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This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 (vandetanib) | Drug | 100 mg once daily oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE. | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. |
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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 | Little Rock | Arkansas | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20371662 | Background | Robinson BG, Paz-Ares L, Krebs A, Vasselli J, Haddad R. Vandetanib (100 mg) in patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2664-71. doi: 10.1210/jc.2009-2461. Epub 2010 Apr 6. |
| Label | URL |
|---|---|
| Related Info | View source |
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22 participants were screened; 19 participants received treatment.
From 29 August 2006 to 31 January 2008, 19 participants in 9 centers in 8 global countries received 100 mg vandetanib.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZD6474 (ZACTIMA™) 100 mg | ZD6474 (ZACTIMA™)100 mg daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
| Disease Control Rate (DCR) | Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
| World Heath Organization (WHO) Performance Status | Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities | WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment. |
| Symptomatic Response | Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level. | Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment. |
| 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 best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters) |
| Biochemical Response Carcinoembryonic Antigen CEA) | A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met. | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation |
| Boston |
| Massachusetts |
| United States |
| Research Site | St Leonards | Australia |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Pisa | Italy |
| Research Site | Utrecht | Netherlands |
| Research Site | Bucharest | Romania |
| Research Site | Madrid | Spain |
| Research Site | Basel | Switzerland |
| CSR-D4200C00068.pdf | View source |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ZD6474 (ZACTIMA™) 100 mg | ZD6474 (ZACTIMA™)100 mg daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
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| 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 (ORR) | 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) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE. | Posted | Number | Participants | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
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| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. | Posted | Median | 95% Confidence Interval | Months | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
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| Secondary | Disease Control Rate (DCR) | Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks | Posted | Number | Participants | RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. |
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| Secondary | World Heath Organization (WHO) Performance Status | Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities | Posted | Number | Participants | WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment. |
|
| ||||||||||||||||||||||||||||
| Secondary | Symptomatic Response | Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level. | Posted | Number | Participants | Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment. |
|
| ||||||||||||||||||||||||||||
| 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 best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. | Posted | Number | Participants | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters) |
|
| ||||||||||||||||||||||||||||
| Secondary | Biochemical Response Carcinoembryonic Antigen CEA) | A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met. | Posted | Number | Participants | Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation |
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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 | ZD6474 (ZACTIMA™) 100 mg | ZD6474 (ZACTIMA™)100 mg daily | 4 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes Insipidus | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
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| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness Unilateral | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Visual Disturbance | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oral Discomfort | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Mucous Membrane Disorder | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Tinea Pedis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Weight Decreased | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Electrocardiogram Qt Prolonged | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Weight Increased | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Mood Altered | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D018276 | Carcinoma, Medullary |
| C536911 | Familial medullary thyroid carcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
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