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Trial record 1 of 1 for:    D4200C00068
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A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00358956
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : August 31, 2012
Last Update Posted : January 30, 2017
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 19
Recruitment Details From 29 August 2006 to 31 January 2008, 19 participants in 9 centers in 8 global countries received 100 mg vandetanib.
Pre-assignment Details 22 participants were screened; 19 participants received treatment.
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description ZD6474 (ZACTIMA™)100 mg daily
Period Title: Overall Study
Started 19
Completed 11 [1]
Not Completed 8
Reason Not Completed
Adverse Event             3
condition under investigation worsened             4
Withdrawal by Subject             1
[1]
ongoing study treatment at data cut-off
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
44.7
(22 to 79)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
6
  31.6%
Male
13
  68.4%
1.Primary Outcome
Title Objective Response Rate (ORR)
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) 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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
3
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Months
16.2
(6.8 to 38.6)
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide 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) >= 24 weeks
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
13
4.Secondary Outcome
Title World Heath Organization (WHO) Performance Status
Hide Description 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
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
0
5.Secondary Outcome
Title Symptomatic Response
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
0
6.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 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
3
7.Secondary Outcome
Title Biochemical Response Carcinoembryonic Antigen CEA)
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description:
ZD6474 (ZACTIMA™)100 mg daily
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZD6474 (ZACTIMA™) 100 mg
Hide Arm/Group Description ZD6474 (ZACTIMA™)100 mg daily
All-Cause Mortality
ZD6474 (ZACTIMA™) 100 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZD6474 (ZACTIMA™) 100 mg
Affected / at Risk (%)
Total   4/19 (21.05%) 
Endocrine disorders   
Diabetes Insipidus  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Phaeochromocytoma  1  2/19 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia Aspiration  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZD6474 (ZACTIMA™) 100 mg
Affected / at Risk (%)
Total   18/19 (94.74%) 
Ear and labyrinth disorders   
Deafness Unilateral  1  1/19 (5.26%) 
Endocrine disorders   
Hypothyroidism  1  2/19 (10.53%) 
Eye disorders   
Conjunctivitis  1  1/19 (5.26%) 
Diplopia  1  1/19 (5.26%) 
Visual Disturbance  1  1/19 (5.26%) 
Gastrointestinal disorders   
Diarrhoea  1  9/19 (47.37%) 
Constipation  1  4/19 (21.05%) 
Nausea  1  3/19 (15.79%) 
Abdominal Pain  1  2/19 (10.53%) 
Dyspepsia  1  2/19 (10.53%) 
Flatulence  1  2/19 (10.53%) 
Dry Mouth  1  1/19 (5.26%) 
Haemorrhoidal Haemorrhage  1  1/19 (5.26%) 
Haemorrhoids  1  1/19 (5.26%) 
Oral Discomfort  1  1/19 (5.26%) 
Vomiting  1  1/19 (5.26%) 
General disorders   
Fatigue  1  9/19 (47.37%) 
Asthenia  1  2/19 (10.53%) 
Influenza Like Illness  1  1/19 (5.26%) 
Malaise  1  1/19 (5.26%) 
Mucous Membrane Disorder  1  1/19 (5.26%) 
Thirst  1  1/19 (5.26%) 
Infections and infestations   
Folliculitis  1  2/19 (10.53%) 
Nasopharyngitis  1  2/19 (10.53%) 
Bronchitis  1  1/19 (5.26%) 
Furuncle  1  1/19 (5.26%) 
Paronychia  1  1/19 (5.26%) 
Pharyngitis  1  1/19 (5.26%) 
Tinea Pedis  1  1/19 (5.26%) 
Upper Respiratory Tract Infection  1  1/19 (5.26%) 
Weight Decreased  1  2/19 (10.53%) 
Electrocardiogram Qt Prolonged  1  1/19 (5.26%) 
Weight Increased  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Anorexia  1  4/19 (21.05%) 
Hypocalcaemia  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  3/19 (15.79%) 
Arthralgia  1  2/19 (10.53%) 
Mobility Decreased  1  1/19 (5.26%) 
Muscle Spasms  1  1/19 (5.26%) 
Muscular Weakness  1  1/19 (5.26%) 
Myalgia  1  1/19 (5.26%) 
Neck Pain  1  1/19 (5.26%) 
Nervous system disorders   
Headache  1  2/19 (10.53%) 
Dizziness  1  1/19 (5.26%) 
Dysarthria  1  1/19 (5.26%) 
Paraesthesia  1  1/19 (5.26%) 
Peripheral Sensory Neuropathy  1  1/19 (5.26%) 
Psychiatric disorders   
Anxiety  1  2/19 (10.53%) 
Insomnia  1  2/19 (10.53%) 
Mood Altered  1  1/19 (5.26%) 
Renal and urinary disorders   
Nephrolithiasis  1  1/19 (5.26%) 
Proteinuria  1  1/19 (5.26%) 
Renal Failure  1  1/19 (5.26%) 
Reproductive system and breast disorders   
Erectile Dysfunction  1  1/19 (5.26%) 
Menorrhagia  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/19 (5.26%) 
Dysphonia  1  1/19 (5.26%) 
Dyspnoea Exertional  1  1/19 (5.26%) 
Haemoptysis  1  1/19 (5.26%) 
Pharyngolaryngeal Pain  1  1/19 (5.26%) 
Upper Respiratory Tract Congestion  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Rash  1  5/19 (26.32%) 
Photosensitivity Reaction  1  3/19 (15.79%) 
Dermatitis Acneiform  1  2/19 (10.53%) 
Dry Skin  1  2/19 (10.53%) 
Acne  1  1/19 (5.26%) 
Erythema  1  1/19 (5.26%) 
Pruritus  1  1/19 (5.26%) 
Purpura  1  1/19 (5.26%) 
Rash Erythematous  1  1/19 (5.26%) 
Rash Maculo-Papular  1  1/19 (5.26%) 
Skin Exfoliation  1  1/19 (5.26%) 
Vascular disorders   
Hypertension  1  3/19 (15.79%) 
Flushing  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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: NCT00358956     History of Changes
Other Study ID Numbers: D4200C00068
2006-001354-28 ( EudraCT Number )
First Submitted: July 28, 2006
First Posted: August 1, 2006
Results First Submitted: April 27, 2011
Results First Posted: August 31, 2012
Last Update Posted: January 30, 2017