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Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00098345
First received: December 7, 2004
Last updated: June 19, 2017
Last verified: June 2017
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Thyroid Cancer
Intervention: Drug: ZD6474 (vandetanib)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
40 patients were enrolled/screened to the study but only 30 patients were entered treatment/randomized.

Reporting Groups
  Description
Caprelsa (Vandetanib) 300 mg Daily oral dose of Caprelsa (vandetanib) 300mg

Participant Flow:   Overall Study
    Caprelsa (Vandetanib) 300 mg
STARTED   30 
COMPLETED   17 [1] 
NOT COMPLETED   13 
Adverse Event                7 
Withdrawal by Subject                2 
progression                4 
[1] ongoing study treatment at data cut-off



  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
Caprelsa (Vandetanib) 300 mg Daily oral dose of Caprelsa (vandetanib) 300mg

Baseline Measures
   Caprelsa (Vandetanib) 300 mg 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Full Range)
 48.7 
 (20 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  70.0% 
Male      9  30.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

3.  Secondary:   Duration of Objective Response   [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

4.  Secondary:   Disease Control Rate   [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]

5.  Secondary:   Biochemical Response Calcitonin (CTN)   [ 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 ]

6.  Secondary:   Symptomatic Response   [ 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. ]

7.  Secondary:   World Health Organisation (WHO) Performance Status   [ 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. ]


  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
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  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


Publications:

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00098345     History of Changes
Other Study ID Numbers: D4200C00008
LPS14954 ( Other Identifier: Sanofi )
Study First Received: December 7, 2004
Results First Received: April 27, 2011
Last Updated: June 19, 2017