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Trial record 1 of 1 for:    D4200C00008
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Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00098345
Recruitment Status : Completed
First Posted : December 8, 2004
Results First Posted : May 24, 2011
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thyroid Cancer
Intervention Drug: ZD6474 (vandetanib)
Enrollment 40
Recruitment Details 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.
Pre-assignment Details 40 patients were enrolled/screened to the study but only 30 patients were entered treatment/randomized.
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description Daily oral dose of Caprelsa (vandetanib) 300mg
Period Title: Overall Study
Started 30
Completed 17 [1]
Not Completed 13
Reason Not Completed
Adverse Event             7
Withdrawal by Subject             2
progression             4
[1]
ongoing study treatment at data cut-off
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
48.7
(20 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
21
  70.0%
Male
9
  30.0%
1.Primary Outcome
Title Objective Response Rate
Hide 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) defined according to RECIST 1.0.
Time Frame Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
6
2.Secondary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Hide Outcome Measure Data
Hide Analysis Population Description
Upper limit is a censored value
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: months
27.9
(2.56 to 36.11)
3.Secondary Outcome
Title Duration of Objective Response
Hide Description 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.
Time Frame Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: days
310.5
(245 to 402)
4.Secondary Outcome
Title Disease Control Rate
Hide Description 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.
Time Frame Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
22
5.Secondary Outcome
Title Biochemical Response Calcitonin (CTN)
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
24
6.Secondary Outcome
Title Symptomatic Response
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
0
7.Secondary Outcome
Title World Health Organisation (WHO) Performance Status
Hide Description 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)
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description:
Daily oral dose of Caprelsa (vandetanib) 300mg
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
4
Time Frame [Not Specified]
Adverse Event Reporting Description Other (non-serious) adverse events terms were reported as per MedDRA 11.0.
 
Arm/Group Title Caprelsa (Vandetanib) 300 mg
Hide Arm/Group Description Daily oral dose of Caprelsa (vandetanib) 300mg
All-Cause Mortality
Caprelsa (Vandetanib) 300 mg
Affected / at Risk (%)
Total   3/30 (10.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Caprelsa (Vandetanib) 300 mg
Affected / at Risk (%)
Total   14/30 (46.67%) 
Cardiac disorders   
Cardiac Failure  1  1/30 (3.33%) 
Gastrointestinal disorders   
Diarrhoea Haemorrhagic  1  1/30 (3.33%) 
Dysphagia  1  1/30 (3.33%) 
Gastric Ulcer  1  1/30 (3.33%) 
Large Intestine Perforation  1  1/30 (3.33%) 
Nausea  1  2/30 (6.67%) 
Pancreatitis Acute  1  1/30 (3.33%) 
Vomiting  1  1/30 (3.33%) 
General disorders   
Death  1  1/30 (3.33%) 
Infections and infestations   
Abdominal Infection  1  1/30 (3.33%) 
Cystitis  1  1/30 (3.33%) 
Diverticulitis Intestinal Haemorrhagic  1  1/30 (3.33%) 
Empyema  1  1/30 (3.33%) 
Gastroenteritis  1  1/30 (3.33%) 
Pneumonia  1  1/30 (3.33%) 
Sinusitis  1  1/30 (3.33%) 
Injury, poisoning and procedural complications   
Cervical Vertebral Fracture  1  1/30 (3.33%) 
Investigations   
Electrocardiogram Qt Prolonged  1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/30 (3.33%) 
Hypocalcaemia  1  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma  1  1/30 (3.33%) 
Colon Cancer  1  1/30 (3.33%) 
Neoplasm Malignant  1  1/30 (3.33%) 
Nervous system disorders   
Neuropathy Peripheral  1  1/30 (3.33%) 
Seizure  1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders   
Exfoliative Rash  1  1/30 (3.33%) 
Vascular disorders   
Embolism  1  1/30 (3.33%) 
Hot Flush  1  1/30 (3.33%) 
Hypotension  1  1/30 (3.33%) 
1
Term from vocabulary, MedDra 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Caprelsa (Vandetanib) 300 mg
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  3/30 (10.00%) 
Cardiac disorders   
Bradycardia  1  2/30 (6.67%) 
Palpitations  1  3/30 (10.00%) 
Ear and labyrinth disorders   
Tinnitus  1  2/30 (6.67%) 
Eye disorders   
Conjunctivitis  1  2/30 (6.67%) 
Dry Eye  1  2/30 (6.67%) 
Vision Blurred  1  7/30 (23.33%) 
Visual Disturbance  1  3/30 (10.00%) 
Gastrointestinal disorders   
Abdominal Distension  1  2/30 (6.67%) 
Abdominal Pain  1  6/30 (20.00%) 
Constipation  1  11/30 (36.67%) 
Diarrhoea  1  21/30 (70.00%) 
Dry Mouth  1  5/30 (16.67%) 
Dyspepsia  1  6/30 (20.00%) 
Flatulence  1  2/30 (6.67%) 
Gastrooesophageal Reflux Disease  1  2/30 (6.67%) 
Haemorrhoids  1  2/30 (6.67%) 
Nausea  1  19/30 (63.33%) 
Oesophagitis  1  6/30 (20.00%) 
Vomiting  1  12/30 (40.00%) 
General disorders   
Asthenia  1  6/30 (20.00%) 
Chest Discomfort  1  2/30 (6.67%) 
Chills  1  5/30 (16.67%) 
Face Oedema  1  2/30 (6.67%) 
Fatigue  1  19/30 (63.33%) 
Influenza Like Illness  1  2/30 (6.67%) 
Localised Oedema  1  2/30 (6.67%) 
Mucosal Inflammation  1  3/30 (10.00%) 
Oedema  1  2/30 (6.67%) 
Oedema Peripheral  1  7/30 (23.33%) 
Pyrexia  1  4/30 (13.33%) 
Temperature Intolerance  1  6/30 (20.00%) 
Infections and infestations   
Bronchitis  1  2/30 (6.67%) 
Laryngitis  1  2/30 (6.67%) 
Paronychia  1  2/30 (6.67%) 
Sinusitis  1  3/30 (10.00%) 
Upper Respiratory Tract Infection  1  4/30 (13.33%) 
Urinary Tract Infection  1  7/30 (23.33%) 
Injury, poisoning and procedural complications   
Contrast Media Reaction  1  2/30 (6.67%) 
Investigations   
Blood Alkaline Phosphatase Increased  1  2/30 (6.67%) 
Blood Creatinine Increased  1  3/30 (10.00%) 
Blood Urea Increased  1  2/30 (6.67%) 
Electrocardiogram Qt Prolonged  1  7/30 (23.33%) 
Platelet Count Increased  1  2/30 (6.67%) 
Weight Decreased  1  4/30 (13.33%) 
Weight Increased  1  2/30 (6.67%) 
Metabolism and nutrition disorders   
Anorexia  1  13/30 (43.33%) 
Decreased Appetite  1  2/30 (6.67%) 
Dehydration  1  4/30 (13.33%) 
Hypercalcaemia  1  2/30 (6.67%) 
Hypercholesterolaemia  1  2/30 (6.67%) 
Hyperglycaemia  1  3/30 (10.00%) 
Hypocalcaemia  1  7/30 (23.33%) 
Hypokalaemia  1  3/30 (10.00%) 
Hypomagnesaemia  1  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/30 (10.00%) 
Back Pain  1  3/30 (10.00%) 
Muscle Spasms  1  3/30 (10.00%) 
Muscular Weakness  1  3/30 (10.00%) 
Musculoskeletal Chest Pain  1  3/30 (10.00%) 
Musculoskeletal Pain  1  2/30 (6.67%) 
Myalgia  1  4/30 (13.33%) 
Nervous system disorders   
Dizziness  1  8/30 (26.67%) 
Dysgeusia  1  10/30 (33.33%) 
Dyskinesia  1  5/30 (16.67%) 
Headache  1  14/30 (46.67%) 
Paraesthesia  1  3/30 (10.00%) 
Tremor  1  3/30 (10.00%) 
Psychiatric disorders   
Anxiety  1  6/30 (20.00%) 
Depression  1  3/30 (10.00%) 
Insomnia  1  6/30 (20.00%) 
Renal and urinary disorders   
Haematuria  1  2/30 (6.67%) 
Nephrolithiasis  1  4/30 (13.33%) 
Proteinuria  1  2/30 (6.67%) 
Urinary Retention  1  3/30 (10.00%) 
Reproductive system and breast disorders   
Menstruation Irregular  1  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  2/30 (6.67%) 
Cough  1  7/30 (23.33%) 
Dyspnoea  1  6/30 (20.00%) 
Dyspnoea Exertional  1  3/30 (10.00%) 
Epistaxis  1  3/30 (10.00%) 
Paranasal Sinus Hypersecretion  1  3/30 (10.00%) 
Pharyngolaryngeal Pain  1  2/30 (6.67%) 
Productive Cough  1  3/30 (10.00%) 
Sinus Congestion  1  6/30 (20.00%) 
Skin and subcutaneous tissue disorders   
Acne  1  6/30 (20.00%) 
Alopecia  1  5/30 (16.67%) 
Dermatitis  1  4/30 (13.33%) 
Dermatitis Acneiform  1  5/30 (16.67%) 
Dry Skin  1  9/30 (30.00%) 
Erythema  1  2/30 (6.67%) 
Periorbital Oedema  1  2/30 (6.67%) 
Photosensitivity Reaction  1  6/30 (20.00%) 
Pruritus  1  4/30 (13.33%) 
Rash  1  20/30 (66.67%) 
Rash Erythematous  1  2/30 (6.67%) 
Vascular disorders   
Flushing  1  3/30 (10.00%) 
Hot Flush  1  4/30 (13.33%) 
Hypertension  1  10/30 (33.33%) 
1
Term from vocabulary, MedDra 20.0
Indicates events were collected by systematic assessment
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
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00098345     History of Changes
Other Study ID Numbers: D4200C00008
LPS14954 ( Other Identifier: Sanofi )
First Submitted: December 7, 2004
First Posted: December 8, 2004
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: May 7, 2018