Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126568
First received: August 2, 2005
Last updated: May 7, 2014
Last verified: December 2012
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Thyroid Cancer
Recurrent Thyroid Cancer
Intervention: Drug: sorafenib tosylate

  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
Subjects recruited from June 2005 to April 2011 from medical clinics

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
BAY 43-9006 BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).

Participant Flow:   Overall Study
    BAY 43-9006  
STARTED     20  
COMPLETED     18 [1]
NOT COMPLETED     2  
Death                 2  
[1] Disease progression at beginning of study, not evaluable



  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
BAY 43-9006 BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).

Baseline Measures
    BAY 43-9006  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 28 to 79 )  
Gender  
[units: participants]
 
Female     7  
Male     13  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     17  
Unknown or Not Reported     3  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     20  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Number of Patients With Response to Treatment Measured by RECIST Criteria   [ Time Frame: at 6 months after treatment ]

2.  Secondary:   Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.   [ Time Frame: 27 months ]

3.  Secondary:   Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.   [ Time Frame: 27 months ]

4.  Secondary:   To Further Characterize the Safety Profile of BAY 43-9006 When Given to Patients With Advanced Anaplastic Carcinoma of the Thyroid.   [ Time Frame: weekly ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
The study met the pre-specified criteria for enrollment of all planned 32 patients. However due to poor accrual the study was halted.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Panayiotis Savvides
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
phone: 216-844-5946
e-mail: Panayiotis.Savvides@uhhospitals.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126568     History of Changes
Other Study ID Numbers: NCI-2009-00118, NCI-2009-00118, CASE 5304, CDR0000437789, CASE 5304, 7037, U01CA062502
Study First Received: August 2, 2005
Results First Received: May 23, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration