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Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment (88)

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ClinicalTrials.gov Identifier: NCT01298323
Recruitment Status : Active, not recruiting
First Posted : February 17, 2011
Results First Posted : November 24, 2014
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Locally Advanced or Metastatic Medullary Thyroid Cancer
Medullary Thyroid Cancer
Interventions Behavioral: Patient outreach
Drug: Vandetanib
Enrollment 205
Recruitment Details From 25 February 2011 to 27 April 2012, 205 patients were randomized by 33 centers in global 20 countries.
Pre-assignment Details 217 patients were screened; 205 patients were randomized to treatment.
Arm/Group Title Vandetanib 300mg Vandetanib 300mg + Outreach Program
Hide Arm/Group Description Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
Period Title: Overall Study
Started 102 103
Ongoing 55 55
Completed 16 15
Not Completed 86 88
Reason Not Completed
Adverse Event             2             4
Death             11             16
Lost to Follow-up             1             0
Withdrawal by Subject             6             3
Protocol Violation             1             0
Other             10             9
Ongoing             55             55
Eligibility criteria not fulfilled             0             1
Arm/Group Title Vandetanib 300mg Vandetanib 300mg + Outreach Program Total
Hide Arm/Group Description Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily Total of all reporting groups
Overall Number of Baseline Participants 102 103 205
Hide Baseline Analysis Population Description
Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 103 participants 205 participants
50.8  (13.47) 53.0  (14.34) 51.9  (13.93)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 103 participants 205 participants
>=18 - <40 Years 21 23 44
>=40 - <65 Years 65 52 117
>=65 - <75 Years 15 22 37
>=75 Years 1 6 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 103 participants 205 participants
Female
38
  37.3%
37
  35.9%
75
  36.6%
Male
64
  62.7%
66
  64.1%
130
  63.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 103 participants 205 participants
Asian 15 19 34
White 87 84 171
1.Primary Outcome
Title Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
Hide Description The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.
Arm/Group Title Vandetanib 300 mg+Outreach Program Vandetanib 300 mg
Hide Arm/Group Description:
Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
Overall Number of Participants Analyzed 102 103
Overall Number of Units Analyzed
Type of Units Analyzed: Months
1513 1480
Mean (Standard Deviation)
Unit of Measure: Percentage of days
51.65  (35.548) 45.19  (36.347)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vandetanib 300 mg+Outreach Program, Vandetanib 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments Statistical significance threshold at this analysis was 10%
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter t-Statistic
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-3.44 to 16.37
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Of 103 patients randomized to vandetanib 300 mg+outreach arm, all except 1 patient took part in outreach program . This patient was withdrawn due to eligibility criteria failure and could not be contacted successfully. Hence the results have been summarized under vandetanib 300 mg for safety summaries.
 
Arm/Group Title Vandetanib 300mg Vandetanib 300mg + Outreach Program
Hide Arm/Group Description Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
All-Cause Mortality
Vandetanib 300mg Vandetanib 300mg + Outreach Program
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vandetanib 300mg Vandetanib 300mg + Outreach Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/103 (29.13%)      27/102 (26.47%)    
Cardiac disorders     
Atrial fibrillation  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Angina pectoris  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Cardiac arrest  1  0/103 (0.00%)  0 2/102 (1.96%)  2
Myocardial infarction  1  1/103 (0.97%)  1 1/102 (0.98%)  1
Endocrine disorders     
Ectopic ACTH syndrome  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Gastrointestinal disorders     
Abdominal pain upper  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Large intestine perforation  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Rectal haemorrhage  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Abdominal pain  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Crohn's disease  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Diarrhoea  1  0/103 (0.00%)  0 3/102 (2.94%)  3
Enteritis  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Haematemesis  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Ileus paralytic  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Intestinal obstruction  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Pancreatitis  1  2/103 (1.94%)  3 0/102 (0.00%)  0
Toothache  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Vomiting  1  0/103 (0.00%)  0 1/102 (0.98%)  1
General disorders     
Asthenia  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Catheter site pain  1  1/103 (0.97%)  2 0/102 (0.00%)  0
Chest pain  1  2/103 (1.94%)  2 0/102 (0.00%)  0
Death  1  2/103 (1.94%)  2 0/102 (0.00%)  0
Sudden death  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Jaundice  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Infections and infestations     
Anal abscess  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Abscess limb  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Appendicitis  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Gastroenteritis caliciviral  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Gastroenteritis viral  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Lung infection  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Pneumonia  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Upper respiratory tract infection  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Urinary tract infection  1  1/103 (0.97%)  2 1/102 (0.98%)  1
Injury, poisoning and procedural complications     
Joint dislocation  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Radius fracture  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Investigations     
Haematocrit increased  1  1/103 (0.97%)  1 1/102 (0.98%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Hypercalcaemia  1  1/103 (0.97%)  1 1/102 (0.98%)  1
Cachexia  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Hyperglycaemia  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Hypocalcaemia  1  2/103 (1.94%)  2 0/102 (0.00%)  0
Hypoglycaemia  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Musculoskeletal and connective tissue disorders     
Neck pain  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Pathological fracture  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Scoliosis  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic pain  1  1/103 (0.97%)  1 1/102 (0.98%)  1
Prostate cancer  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Nervous system disorders     
Vocal cord paralysis  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Epilepsy  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Migraine with aura  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Sciatica  1  1/103 (0.97%)  2 0/102 (0.00%)  0
Psychiatric disorders     
Depression  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Fear  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Renal and urinary disorders     
Nephrolithiasis  1  0/103 (0.00%)  0 1/102 (0.98%)  2
Azotaemia  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Glomerulonephritis  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Renal failure  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Respiratory, thoracic and mediastinal disorders     
Productive cough  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Pulmonary embolism  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Dyspnoea  1  1/103 (0.97%)  1 1/102 (0.98%)  1
Haemoptysis  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Laryngeal dyspnoea  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Skin and subcutaneous tissue disorders     
Photosensitivity reaction  1  1/103 (0.97%)  1 0/102 (0.00%)  0
Vascular disorders     
Venous insufficiency  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Hypertension  1  2/103 (1.94%)  2 2/102 (1.96%)  3
Hypertensive crisis  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Hypotension  1  0/103 (0.00%)  0 1/102 (0.98%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 300mg Vandetanib 300mg + Outreach Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/103 (86.41%)      96/102 (94.12%)    
Endocrine disorders     
Hypothyroidism  1  15/103 (14.56%)  16 15/102 (14.71%)  16
Gastrointestinal disorders     
Constipation  1  5/103 (4.85%)  5 8/102 (7.84%)  9
Diarrhoea  1  48/103 (46.60%)  63 55/102 (53.92%)  85
Dry mouth  1  4/103 (3.88%)  4 7/102 (6.86%)  7
Nausea  1  19/103 (18.45%)  21 26/102 (25.49%)  34
Vomiting  1  11/103 (10.68%)  13 8/102 (7.84%)  8
General disorders     
Asthenia  1  12/103 (11.65%)  13 12/102 (11.76%)  14
Fatigue  1  17/103 (16.50%)  17 18/102 (17.65%)  19
Investigations     
Alanine aminotransferase increased  1  10/103 (9.71%)  10 9/102 (8.82%)  9
Aspartate aminotransferase increased  1  8/103 (7.77%)  8 5/102 (4.90%)  6
Blood creatinine increased  1  8/103 (7.77%)  9 5/102 (4.90%)  5
Electrocardiogram QT prolonged  1  7/103 (6.80%)  12 9/102 (8.82%)  13
Weight decreased  1  11/103 (10.68%)  11 12/102 (11.76%)  12
Metabolism and nutrition disorders     
Decreased appetite  1  19/103 (18.45%)  20 13/102 (12.75%)  15
Hypocalcaemia  1  14/103 (13.59%)  18 13/102 (12.75%)  14
Musculoskeletal and connective tissue disorders     
Myalgia  1  4/103 (3.88%)  4 9/102 (8.82%)  11
Nervous system disorders     
Headache  1  8/103 (7.77%)  9 12/102 (11.76%)  16
Dizziness  1  3/103 (2.91%)  4 7/102 (6.86%)  8
Dysgeusia  1  6/103 (5.83%)  6 0/102 (0.00%)  0
Psychiatric disorders     
Anxiety  1  7/103 (6.80%)  7 4/102 (3.92%)  4
Insomnia  1  9/103 (8.74%)  9 8/102 (7.84%)  10
Renal and urinary disorders     
Proteinuria  1  8/103 (7.77%)  8 11/102 (10.78%)  15
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/103 (0.97%)  1 6/102 (5.88%)  6
Skin and subcutaneous tissue disorders     
Erythema  1  2/103 (1.94%)  2 6/102 (5.88%)  6
Rash  1  25/103 (24.27%)  31 26/102 (25.49%)  28
Rash maculo-papular  1  7/103 (6.80%)  7 4/102 (3.92%)  4
Acne  1  10/103 (9.71%)  11 7/102 (6.86%)  9
Alopecia  1  8/103 (7.77%)  8 2/102 (1.96%)  2
Dermatitis acneiform  1  22/103 (21.36%)  23 22/102 (21.57%)  24
Dry skin  1  12/103 (11.65%)  12 7/102 (6.86%)  8
Palmar-plantar erythrodysaesthesia syndrome  1  6/103 (5.83%)  6 5/102 (4.90%)  5
Photosensitivity reaction  1  7/103 (6.80%)  8 13/102 (12.75%)  18
Vascular disorders     
Hypertension  1  31/103 (30.10%)  35 35/102 (34.31%)  40
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01298323    
Other Study ID Numbers: D4200C00088
2010-023428-26 ( EudraCT Number )
LPS14815 ( Other Identifier: Sanofi )
First Submitted: February 16, 2011
First Posted: February 17, 2011
Results First Submitted: April 25, 2014
Results First Posted: November 24, 2014
Last Update Posted: January 14, 2021