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To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01496313
Recruitment Status : Active, not recruiting
First Posted : December 21, 2011
Results First Posted : November 27, 2015
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Thyroid Cancer
Interventions Drug: 300mg vandetanib
Drug: 150mg vandetanib
Enrollment 81
Recruitment Details From 8 June 2012 to 2 April 2014, 81 participants were randomized by 29 centers in 9 global countries.
Pre-assignment Details 93 participants were screened; 81 participants were randomized to treatment.
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description Oral blinded tablet, taken once daily Oral blinded tablet, taken once daily
Period Title: Overall Study
Started 40 41
Completed 35 26
Not Completed 5 15
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg Total
Hide Arm/Group Description Oral blinded tablet, taken once daily Oral blinded tablet, taken once daily Total of all reporting groups
Overall Number of Baseline Participants 40 41 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 81 participants
52.2  (15.24) 52.7  (15.42) 52.5  (15.24)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
>=18 to <40 years 9 9 18
>=40 to <65 years 22 20 42
>=65 to <75 years 7 10 17
>=75 years 2 2 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
Female
15
  37.5%
12
  29.3%
27
  33.3%
Male
25
  62.5%
29
  70.7%
54
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
Asian 1 2 3
Black or African American 0 1 1
White 39 37 76
Other 0 1 1
1.Primary Outcome
Title Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
Hide Description ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Time Frame Randomisation to week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 40 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.20
(0.105 to 0.348)
0.29
(0.176 to 0.445)
2.Secondary Outcome
Title Best Objective Response
Hide Description [Not Specified]
Time Frame Randomisation to week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 40 41
Measure Type: Number
Unit of Measure: Participants
Complete response 0 1
Partial response 8 11
Stable disease 21 23
Progressive disease 9 2
Non-evaluable 2 4
3.Secondary Outcome
Title Duration of Objective Response (RECIST 1.1) by Treatment Arm
Hide Description [Not Specified]
Time Frame Randomization to Week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 8 12
Median (95% Confidence Interval)
Unit of Measure: Months
9.8
(2.8 to 11.2)
8.4
(3.0 to 11.2)
4.Secondary Outcome
Title Time to Objective Response (RECIST 1.1) by Treatment Arm
Hide Description [Not Specified]
Time Frame Randomization to Week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 8 12
Median (95% Confidence Interval)
Unit of Measure: Months
4.2
(2.8 to 11.2)
4.4
(2.8 to 11.1)
5.Secondary Outcome
Title Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Hide Description [Not Specified]
Time Frame Randomization to Week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: % change
Week 12 -3.8  (29.24) -17.5  (18.24)
Week 24 -13.0  (19.51) -24.9  (22.11)
Week 36 -16.7  (24.33) -29.1  (22.96)
Week 48 -20.7  (23.56) -30.6  (25.31)
Follow-up RECIST assessment -51.0  (0) -11.4  (67.05)
Disc. of blinded vandetanib -11.9  (27.98) -27.3  (29.58)
6.Secondary Outcome
Title Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Hide Description [Not Specified]
Time Frame Week 3 to week 60 (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description:
Oral blinded tablet, taken once daily
Oral blinded tablet, taken once daily
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: ng/ml
Week 3 (Day 21) 428.6  (140.71) 786.2  (243.15)
Week 8 (Day 56) 510.5  (206.50) 941.0  (249.4)
Week 12 (Day 84) 561.4  (215.66) 969.9  (396.18)
Week 24 (Day 168) 549.7  (189.62) 1017.7  (330.89)
Discontinuation of blinded vandetanib 536.8  (225.34) 964.0  (357.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 150 mg Vandetanib 300 mg
Hide Arm/Group Description Oral blinded tablet, taken once daily Oral blinded tablet, taken once daily
All-Cause Mortality
Vandetanib 150 mg Vandetanib 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vandetanib 150 mg Vandetanib 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/40 (20.00%)      9/41 (21.95%)    
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/40 (2.50%)  1 0/41 (0.00%)  0
ANGINA PECTORIS  1  1/40 (2.50%)  1 0/41 (0.00%)  0
MYOCARDIAL INFARCTION  1  0/40 (0.00%)  0 1/41 (2.44%)  1
Endocrine disorders     
HYPOTHYROIDISM  1  0/40 (0.00%)  0 1/41 (2.44%)  1
Gastrointestinal disorders     
PANCREATITIS  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Hepatobiliary disorders     
BILE DUCT STONE  1  1/40 (2.50%)  1 0/41 (0.00%)  0
CHOLECYSTITIS  1  0/40 (0.00%)  0 1/41 (2.44%)  1
CHOLECYSTITIS ACUTE  1  0/40 (0.00%)  0 1/41 (2.44%)  1
CHOLELITHIASIS  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Infections and infestations     
VIRAL INFECTION  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Injury, poisoning and procedural complications     
POST PROCEDURAL HAEMATOMA  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Metabolism and nutrition disorders     
HYPOCALCAEMIA  1  1/40 (2.50%)  1 1/41 (2.44%)  1
HYPOMAGNESAEMIA  1  0/40 (0.00%)  0 1/41 (2.44%)  1
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  0/40 (0.00%)  0 1/41 (2.44%)  1
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  1/40 (2.50%)  1 0/41 (0.00%)  0
EPILEPSY  1  0/40 (0.00%)  0 1/41 (2.44%)  1
MILLER FISHER SYNDROME  1  1/40 (2.50%)  1 0/41 (0.00%)  0
PARAESTHESIA  1  1/40 (2.50%)  1 0/41 (0.00%)  0
PERIPHERAL MOTOR NEUROPATHY  1  0/40 (0.00%)  0 1/41 (2.44%)  1
SPINAL CORD COMPRESSION  1  1/40 (2.50%)  1 0/41 (0.00%)  0
TREMOR  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  1/40 (2.50%)  1 0/41 (0.00%)  0
LARYNGEAL OEDEMA  1  1/40 (2.50%)  2 0/41 (0.00%)  0
PNEUMONIA ASPIRATION  1  0/40 (0.00%)  0 1/41 (2.44%)  1
PULMONARY EMBOLISM  1  0/40 (0.00%)  0 1/41 (2.44%)  1
Skin and subcutaneous tissue disorders     
SKIN ULCER  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Vascular disorders     
DEEP VEIN THROMBOSIS  1  1/40 (2.50%)  1 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 150 mg Vandetanib 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/40 (97.50%)      40/41 (97.56%)    
Endocrine disorders     
HYPOTHYROIDISM  1  3/40 (7.50%)  3 6/41 (14.63%)  6
Eye disorders     
KERATOPATHY  1  5/40 (12.50%)  5 13/41 (31.71%)  13
Gastrointestinal disorders     
DIARRHOEA  1  15/40 (37.50%)  16 18/41 (43.90%)  20
NAUSEA  1  4/40 (10.00%)  4 5/41 (12.20%)  6
General disorders     
ASTHENIA  1  5/40 (12.50%)  6 6/41 (14.63%)  6
FATIGUE  1  8/40 (20.00%)  8 7/41 (17.07%)  7
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  5/40 (12.50%)  5 7/41 (17.07%)  7
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/40 (7.50%)  3 6/41 (14.63%)  6
BLOOD CREATININE INCREASED  1  5/40 (12.50%)  6 2/41 (4.88%)  2
BLOOD THYROID STIMULATING HORMONE INCREASED  1  11/40 (27.50%)  11 9/41 (21.95%)  11
ELECTROCARDIOGRAM QT PROLONGED  1  5/40 (12.50%)  5 14/41 (34.15%)  15
WEIGHT DECREASED  1  2/40 (5.00%)  2 5/41 (12.20%)  6
Metabolism and nutrition disorders     
DECREASED APPETITE  1  2/40 (5.00%)  2 7/41 (17.07%)  8
HYPOCALCAEMIA  1  8/40 (20.00%)  8 12/41 (29.27%)  13
HYPOKALAEMIA  1  2/40 (5.00%)  3 7/41 (17.07%)  8
HYPOMAGNESAEMIA  1  4/40 (10.00%)  5 7/41 (17.07%)  9
Psychiatric disorders     
INSOMNIA  1  2/40 (5.00%)  2 6/41 (14.63%)  6
Renal and urinary disorders     
PROTEINURIA  1  5/40 (12.50%)  6 3/41 (7.32%)  5
Skin and subcutaneous tissue disorders     
DERMATITIS ACNEIFORM  1  6/40 (15.00%)  7 6/41 (14.63%)  8
DRY SKIN  1  5/40 (12.50%)  5 5/41 (12.20%)  5
RASH  1  8/40 (20.00%)  9 13/41 (31.71%)  19
Vascular disorders     
HYPERTENSION  1  8/40 (20.00%)  10 11/41 (26.83%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: NCT01496313    
Other Study ID Numbers: D4200C00097
2011-004701-24 ( EudraCT Number )
LPS14809 ( Other Identifier: Sanofi )
First Submitted: December 2, 2011
First Posted: December 21, 2011
Results First Submitted: April 1, 2015
Results First Posted: November 27, 2015
Last Update Posted: March 4, 2020