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Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer (VERIFY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01876784
First received: June 11, 2013
Last updated: January 23, 2017
Last verified: January 2017
Results First Received: January 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Differentiated Thyroid Cancer
Interventions: Drug: Vandetanib (SAR390530)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 66 centers in 12 countries. A total of 299 participants were screened between 17 September 2013 and 26 September 2014 of whom 238 participants were randomized and 235 were treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vandetanib Vandetanib 300 mg tablet, orally once daily until disease progression or death.
Placebo Placebo matched to vandetanib tablet, orally once daily until disease progression or death.

Participant Flow:   Overall Study
    Vandetanib   Placebo
STARTED   119   119 
Treated   117   118 
COMPLETED   0   0 
NOT COMPLETED   119   119 
Withdrawal by Subject                17                2 
Adverse Event                15                2 
Protocol Violation                1                0 
Disease progression                37                67 
Lost to Follow-up                0                1 
Death                1                0 
Randomized but not treated                2                1 
Other than specified above                5                6 
Ongoing                41                40 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vandetanib Vandetanib 300 mg tablet, orally once daily until disease progression or death.
Placebo Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
Total Total of all reporting groups

Baseline Measures
   Vandetanib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   119   238 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (9.69)   63.2  (11.02)   63.7  (10.36) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      70  58.8%      64  53.8%      134  56.3% 
Male      49  41.2%      55  46.2%      104  43.7% 


  Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization until disease progression or death, assessed every 12 weeks (up to 22 months) ]

2.  Secondary:   Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Duration of Response.   [ Time Frame: Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Demonstration of an Improvement in Time to Worsening of Pain in Patients Treated With Vandetanib When Compared to Placebo in the Patient Population.   [ Time Frame: Patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Evaluation of the Safety and Tolerability of Vandetanib Treatment in the Patient Population by Assessment of Adverse Events, Vital Signs, Laboratory Parameters and Electrocardiography.   [ Time Frame: Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Objective Response Rate.   [ Time Frame: Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Change in Tumour Size   [ Time Frame: Assessed tumour size at screening, Weeks 7, 8 and then every 12 weeks thereafter and at Discontinuation visit, estimated time frame at 25.5 months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Overall Survival   [ Time Frame: Estimated time frame at 20 months after initial 25.5 months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of V/F.   [ Time Frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of Cmax   [ Time Frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of AUCss   [ Time Frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of CL/F   [ Time Frame: Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com



Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01876784     History of Changes
Other Study ID Numbers: D4203C00011
2013-000422-58 ( EudraCT Number )
LPS14813 ( Other Identifier: Sanofi )
Study First Received: June 11, 2013
Results First Received: January 23, 2017
Last Updated: January 23, 2017