An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00410761

Recruitment Status : Active, not recruiting

First Posted : December 13, 2006

Results First Posted : March 26, 2012

Last Update Posted : October 2, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Thyroid Cancer
Intervention	Drug: ZD6474 (Vandetanib)
Enrollment	437

Participant Flow

Recruitment Details	First patient enrolled 23 November 2006, last patient enrolled 19 October 2007, cut off date 31 July 2009. 437 patients were enrolled.
Pre-assignment Details


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description	Vandetanib (300 mg daily)	Placebo daily
Period Title: Overall Study
Started	231 ^[1]	100 ^[1]
Completed	111 ^[2]	28 ^[2]
Not Completed	120	72
Reason Not Completed
Adverse Event	29	3
objective disease progression	71	55
Withdrawal by Subject	8	4
Other	12	9
Never received randomised treatment	0	1
[1] randomised patients [2] ongoing study treatment at data cut-off

Baseline Characteristics

Arm/Group Title		Vandetanib 300 mg	Placebo	Total
Arm/Group Description		Vandetanib (300 mg daily)	Placebo daily	Total of all reporting groups
Arm/Group Description		Vandetanib (300 mg daily)	Placebo daily	Total of all reporting groups
Overall Number of Baseline Participants		231	100	331
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	231 participants	100 participants	331 participants
		50.7 (18 to 83)	53.4 (26 to 84)	52 (18 to 84)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	231 participants	100 participants	331 participants
	Female	97 42.0%	44 44.0%	141 42.6%
	Male	134 58.0%	56 56.0%	190 57.4%

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival(PFS)
Description	Median time to progression (months) from randomisation until objective...
Description	Median time to progression (months) 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. Values here are estimated (from a Weibull model) as the medians were not met.
Time Frame	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Median (95% Confidence Interval) Unit of Measure: Months
	30.5 ^[1] (NA to NA)	19.2 ^[1] (NA to NA)

[1]

PFS is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median

2.Secondary Outcome


Title	Objective Response Rate (ORR)
Description	The ORR is the number of patients that are responders ie those patient...
Description	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.
Time Frame	RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Participants
	104	13

3.Secondary Outcome


Title	Disease Control Rate (DCR)
Description	Disease control rate is defined as the number of patients who achieved...
Description	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) >= 12 weeks
Time Frame	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Participants
	200	71

4.Secondary Outcome


Title	Duration of Response (DoR)
Description	Response is defined as a confirmed best objective response of CR or PR...
Description	Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met
Time Frame	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

Outcome Measure Data

Analysis Population Description

DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	104	13
Median (95% Confidence Interval) Unit of Measure: Months
	22.2 ^[1] (NA to NA)	16.3 ^[1] (NA to NA)

[1]

DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median

5.Secondary Outcome


Title	Overall Survival (OS)
Description	As data was immature at data cut off, number of death events is quoted
Description	As data was immature at data cut off, number of death events is quoted
Time Frame	Number of deaths since randomisation

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Participants
	32	16

6.Secondary Outcome


Title	Biochemical Response Calcitonin (CTN)
Description	Best biochemical response was calculated from assessments at baseline ...
Description	Best biochemical response was calculated from assessments 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. CR and PR being defined according to level of CTN.
Time Frame	Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Participants
	160	3

7.Secondary Outcome


Title	Biochemical Response Carcinoembryonic Antigen (CEA)
Description	Best biochemical response was calculated from assessments at baseline ...
Description	Best biochemical response was calculated from assessments 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. CR and PR being defined according to level of CEA.
Time Frame	Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Participants
	119	2

8.Secondary Outcome


Title	Time to Worsening of Pain (TWP)
Description	TWP was derived using the worst pain score from brief pain inventory (...
Description	TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.
Time Frame	During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description:	Vandetanib (300 mg daily)	Placebo daily
Overall Number of Participants Analyzed	231	100
Measure Type: Number Unit of Measure: Weeks
	7.8	3.3

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Vandetanib 300 mg	Placebo
Arm/Group Description	Vandetanib (300 mg daily)	Placebo daily
Arm/Group Description	Vandetanib (300 mg daily)	Placebo daily
All-Cause Mortality
	Vandetanib 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Vandetanib 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	71/231 (30.74%)	13/99 (13.13%)
Blood and lymphatic system disorders
Thrombocytopenia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Cardiac disorders
Arrhythmia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Atrial Fibrillation ^† 1	1/231 (0.43%)	0/99 (0.00%)
Bradycardia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Cardiac Failure Acute ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pericardial Effusion ^† 1	0/231 (0.00%)	1/99 (1.01%)
Pericardial Haemorrhage ^† 1	0/231 (0.00%)	1/99 (1.01%)
Pericarditis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Eye disorders
Glaucoma ^† 1	1/231 (0.43%)	0/99 (0.00%)
Vision Blurred ^† 1	1/231 (0.43%)	0/99 (0.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	5/231 (2.16%)	0/99 (0.00%)
Abdominal Pain ^† 1	3/231 (1.30%)	0/99 (0.00%)
Dysphagia ^† 1	2/231 (0.87%)	0/99 (0.00%)
Vomiting ^† 1	2/231 (0.87%)	0/99 (0.00%)
Colitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Gastritis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Gastrointestinal Haemorrhage ^† 1	1/231 (0.43%)	1/99 (1.01%)
Ileus ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pancreatitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Peritonitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pneumatosis Intestinalis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Small Intestinal Perforation ^† 1	1/231 (0.43%)	0/99 (0.00%)
General disorders
Asthenia ^† 1	2/231 (0.87%)	0/99 (0.00%)
Chest Pain ^† 1	1/231 (0.43%)	0/99 (0.00%)
Fatigue ^† 1	1/231 (0.43%)	1/99 (1.01%)
General Physical Health Deterioration ^† 1	1/231 (0.43%)	1/99 (1.01%)
Mucosal Inflammation ^† 1	1/231 (0.43%)	0/99 (0.00%)
Hepatobiliary disorders
Cholecystitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Cholelithiasis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Immune system disorders
Iodine Allergy ^† 1	0/231 (0.00%)	1/99 (1.01%)
Infections and infestations
Pneumonia ^† 1	5/231 (2.16%)	0/99 (0.00%)
Urinary Tract Infection ^† 1	3/231 (1.30%)	0/99 (0.00%)
Appendicitis ^† 1	2/231 (0.87%)	0/99 (0.00%)
Bronchitis ^† 1	2/231 (0.87%)	1/99 (1.01%)
Diverticulitis ^† 1	2/231 (0.87%)	0/99 (0.00%)
Sepsis ^† 1	2/231 (0.87%)	0/99 (0.00%)
Abdominal Wall Abscess ^† 1	1/231 (0.43%)	0/99 (0.00%)
Gastroenteritis ^† 1	0/231 (0.00%)	1/99 (1.01%)
Gastroenteritis Bacterial ^† 1	1/231 (0.43%)	0/99 (0.00%)
Gastroenteritis Viral ^† 1	1/231 (0.43%)	0/99 (0.00%)
Infected Bites ^† 1	1/231 (0.43%)	0/99 (0.00%)
Laryngitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pyelonephritis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Staphylococcal Infection ^† 1	1/231 (0.43%)	0/99 (0.00%)
Staphylococcal Sepsis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Tracheitis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Injury, poisoning and procedural complications
Jaw Fracture ^† 1	0/231 (0.00%)	1/99 (1.01%)
Joint Injury ^† 1	1/231 (0.43%)	0/99 (0.00%)
Overdose ^† 1	0/231 (0.00%)	1/99 (1.01%)
Stent Occlusion ^† 1	1/231 (0.43%)	0/99 (0.00%)
Venomous Bite ^† 1	1/231 (0.43%)	0/99 (0.00%)
C-Reactive Protein Increased ^† 1	1/231 (0.43%)	0/99 (0.00%)
Electrocardiogram Qt Prolonged ^† 1	1/231 (0.43%)	0/99 (0.00%)
International Normalised Ratio Increased ^† 1	1/231 (0.43%)	0/99 (0.00%)
Prostatic Specific Antigen Increased ^† 1	0/231 (0.00%)	1/99 (1.01%)
Metabolism and nutrition disorders
Decreased Appetite ^† 1	4/231 (1.73%)	0/99 (0.00%)
Hypercalcaemia ^† 1	3/231 (1.30%)	0/99 (0.00%)
Dehydration ^† 1	2/231 (0.87%)	0/99 (0.00%)
Hypocalcaemia ^† 1	2/231 (0.87%)	0/99 (0.00%)
Hypokalaemia ^† 1	2/231 (0.87%)	0/99 (0.00%)
Diabetes Mellitus ^† 1	0/231 (0.00%)	1/99 (1.01%)
Hypoglycaemia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Hyponatraemia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Malnutrition ^† 1	1/231 (0.43%)	0/99 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma ^† 1	0/231 (0.00%)	1/99 (1.01%)
Metastases To Bone ^† 1	1/231 (0.43%)	0/99 (0.00%)
Phaeochromocytoma ^† 1	0/231 (0.00%)	1/99 (1.01%)
Nervous system disorders
Loss Of Consciousness ^† 1	2/231 (0.87%)	0/99 (0.00%)
Transient Ischaemic Attack ^† 1	2/231 (0.87%)	0/99 (0.00%)
Brain Oedema ^† 1	1/231 (0.43%)	0/99 (0.00%)
Cerebral Ischaemia ^† 1	1/231 (0.43%)	0/99 (0.00%)
Depressed Level Of Consciousness ^† 1	1/231 (0.43%)	0/99 (0.00%)
Hemiparesis ^† 1	0/231 (0.00%)	1/99 (1.01%)
Neuralgia ^† 1	0/231 (0.00%)	1/99 (1.01%)
Peripheral Sensorimotor Neuropathy ^† 1	1/231 (0.43%)	0/99 (0.00%)
Psychiatric disorders
Depression ^† 1	3/231 (1.30%)	0/99 (0.00%)
Bipolar Disorder ^† 1	1/231 (0.43%)	0/99 (0.00%)
Renal and urinary disorders
Nephrolithiasis ^† 1	2/231 (0.87%)	0/99 (0.00%)
Anuria ^† 1	1/231 (0.43%)	0/99 (0.00%)
Calculus Ureteric ^† 1	1/231 (0.43%)	0/99 (0.00%)
Renal Colic ^† 1	1/231 (0.43%)	0/99 (0.00%)
Renal Failure ^† 1	1/231 (0.43%)	0/99 (0.00%)
Tubulointerstitial Nephritis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis ^† 1	2/231 (0.87%)	0/99 (0.00%)
Bronchospasm ^† 1	1/231 (0.43%)	0/99 (0.00%)
Chylothorax ^† 1	1/231 (0.43%)	0/99 (0.00%)
Dyspnoea ^† 1	1/231 (0.43%)	0/99 (0.00%)
Haemoptysis ^† 1	1/231 (0.43%)	1/99 (1.01%)
Pleural Effusion ^† 1	0/231 (0.00%)	1/99 (1.01%)
Pneumonia Aspiration ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pulmonary Thrombosis ^† 1	0/231 (0.00%)	1/99 (1.01%)
Respiratory Arrest ^† 1	1/231 (0.43%)	0/99 (0.00%)
Respiratory Failure ^† 1	1/231 (0.43%)	0/99 (0.00%)
Skin and subcutaneous tissue disorders
Photosensitivity Reaction ^† 1	2/231 (0.87%)	0/99 (0.00%)
Pruritus ^† 1	1/231 (0.43%)	0/99 (0.00%)
Rash ^† 1	1/231 (0.43%)	0/99 (0.00%)
Skin Ulcer ^† 1	1/231 (0.43%)	0/99 (0.00%)
Vascular disorders
Hypertensive Crisis ^† 1	4/231 (1.73%)	0/99 (0.00%)
Hypertension ^† 1	3/231 (1.30%)	0/99 (0.00%)
Accelerated Hypertension ^† 1	1/231 (0.43%)	0/99 (0.00%)
Pelvic Venous Thrombosis ^† 1	1/231 (0.43%)	0/99 (0.00%)
Vena Cava Thrombosis ^† 1	1/231 (0.43%)	0/99 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Vandetanib 300 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	230/231 (99.57%)	90/99 (90.91%)
Endocrine disorders
Hypothyroidism ^† 1	15/231 (6.49%)	0/99 (0.00%)
Eye disorders
Vision Blurred ^† 1	19/231 (8.23%)	1/99 (1.01%)
Gastrointestinal disorders
Diarrhoea ^† 1	128/231 (55.41%)	26/99 (26.26%)
Nausea ^† 1	77/231 (33.33%)	16/99 (16.16%)
Vomiting ^† 1	33/231 (14.29%)	7/99 (7.07%)
Abdominal Pain ^† 1	31/231 (13.42%)	5/99 (5.05%)
Dyspepsia ^† 1	25/231 (10.82%)	4/99 (4.04%)
Abdominal Pain Upper ^† 1	20/231 (8.66%)	5/99 (5.05%)
Dry Mouth ^† 1	20/231 (8.66%)	3/99 (3.03%)
Constipation ^† 1	13/231 (5.63%)	5/99 (5.05%)
Toothache ^† 1	7/231 (3.03%)	5/99 (5.05%)
General disorders
Fatigue ^† 1	54/231 (23.38%)	22/99 (22.22%)
Asthenia ^† 1	33/231 (14.29%)	11/99 (11.11%)
Pyrexia ^† 1	17/231 (7.36%)	3/99 (3.03%)
Infections and infestations
Nasopharyngitis ^† 1	26/231 (11.26%)	9/99 (9.09%)
Upper Respiratory Tract Infection ^† 1	19/231 (8.23%)	3/99 (3.03%)
Influenza ^† 1	16/231 (6.93%)	3/99 (3.03%)
Urinary Tract Infection ^† 1	15/231 (6.49%)	6/99 (6.06%)
Bronchitis ^† 1	10/231 (4.33%)	6/99 (6.06%)
Electrocardiogram Qt Prolonged ^† 1	32/231 (13.85%)	1/99 (1.01%)
Weight Decreased ^† 1	24/231 (10.39%)	9/99 (9.09%)
Metabolism and nutrition disorders
Decreased Appetite ^† 1	46/231 (19.91%)	12/99 (12.12%)
Hypocalcaemia ^† 1	23/231 (9.96%)	3/99 (3.03%)
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	21/231 (9.09%)	20/99 (20.20%)
Arthralgia ^† 1	18/231 (7.79%)	10/99 (10.10%)
Musculoskeletal Chest Pain ^† 1	16/231 (6.93%)	5/99 (5.05%)
Pain In Extremity ^† 1	16/231 (6.93%)	13/99 (13.13%)
Muscle Spasms ^† 1	15/231 (6.49%)	1/99 (1.01%)
Neck Pain ^† 1	14/231 (6.06%)	8/99 (8.08%)
Musculoskeletal Pain ^† 1	12/231 (5.19%)	9/99 (9.09%)
Nervous system disorders
Headache ^† 1	59/231 (25.54%)	9/99 (9.09%)
Dizziness ^† 1	20/231 (8.66%)	6/99 (6.06%)
Dysgeusia ^† 1	19/231 (8.23%)	3/99 (3.03%)
Paraesthesia ^† 1	12/231 (5.19%)	3/99 (3.03%)
Psychiatric disorders
Insomnia ^† 1	30/231 (12.99%)	10/99 (10.10%)
Depression ^† 1	19/231 (8.23%)	3/99 (3.03%)
Anxiety ^† 1	13/231 (5.63%)	5/99 (5.05%)
Renal and urinary disorders
Proteinuria ^† 1	23/231 (9.96%)	2/99 (2.02%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	25/231 (10.82%)	10/99 (10.10%)
Oropharyngeal Pain ^† 1	19/231 (8.23%)	6/99 (6.06%)
Dyspnoea ^† 1	18/231 (7.79%)	9/99 (9.09%)
Epistaxis ^† 1	18/231 (7.79%)	5/99 (5.05%)
Dysphonia ^† 1	15/231 (6.49%)	3/99 (3.03%)
Dyspnoea Exertional ^† 1	3/231 (1.30%)	5/99 (5.05%)
Skin and subcutaneous tissue disorders
Rash ^† 1	103/231 (44.59%)	11/99 (11.11%)
Acne ^† 1	46/231 (19.91%)	5/99 (5.05%)
Dermatitis Acneiform ^† 1	35/231 (15.15%)	2/99 (2.02%)
Dry Skin ^† 1	35/231 (15.15%)	5/99 (5.05%)
Photosensitivity Reaction ^† 1	29/231 (12.55%)	0/99 (0.00%)
Pruritus ^† 1	24/231 (10.39%)	4/99 (4.04%)
Erythema ^† 1	23/231 (9.96%)	3/99 (3.03%)
Alopecia ^† 1	18/231 (7.79%)	0/99 (0.00%)
Vascular disorders
Hypertension ^† 1	72/231 (31.17%)	5/99 (5.05%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Trial Transparency Team
Organization:	Sanofi
EMail:	Contact-US@sanofi.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24. Erratum In: J Clin Oncol. 2013 Aug 20;31(24):3049.

Layout table for additonal information

Responsible Party:	Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:	NCT00410761
Other Study ID Numbers:	D4200C00058 2005-005077-29 ( EudraCT Number ) LPS14811 ( Other Identifier: Sanofi )
First Submitted:	December 6, 2006
First Posted:	December 13, 2006
Results First Submitted:	April 27, 2011
Results First Posted:	March 26, 2012
Last Update Posted:	October 2, 2023

To Top