ClinicalTrials.gov
ClinicalTrials.gov Menu

Pioglitazone in Thyroid Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01655719
Recruitment Status : Completed
First Posted : August 2, 2012
Results First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ronald J. Koenig, MD PhD, University of Michigan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene
Intervention: Drug: Pioglitazone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Pioglitazone Treatment

If eligible, subjects can participate in 1 or both parts of this study as follows:

Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.

Part 2: A secondary protocol is then available to subjects who complete the main initial study with less than complete response per RECIST. They can undergo a radioiodine scan to see if the treatment with pioglitazone has sensitized their disease to radioiodine. If it has - they can pursue the radioiodine treatment.

Pioglitazone


Participant Flow:   Overall Study
    Pioglitazone Treatment
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics

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
Pioglitazone Treatment Part 1: In the initial main portion of the study subjects will receive 24 -28 weeks of therapy with pioglitazone at the dosage approved for the control of diabetes. Response will be evaluated per RECIST. Safety measure are outlined in the protocol including weekly weigh ins, calls, labs, exams, etc.

Baseline Measures
   Pioglitazone Treatment 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      1 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   Tumor Response (Change)   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Change in Serum Thyroglobulin   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   Toxicity   [ Time Frame: 24 weeks ]

4.  Other Pre-specified:   Biomarkers   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Sensitization to Radioiodine Therapy   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Lipid Accumulation in Tumor   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Tim Muth
Organization: University of Michigan
phone: 734-615-8914
e-mail: tmuth@med.umich.edu



Responsible Party: Ronald J. Koenig, MD PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01655719     History of Changes
Other Study ID Numbers: 2011.097
R01CA166033 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2012
First Posted: August 2, 2012
Results First Submitted: August 21, 2017
Results First Posted: October 26, 2017
Last Update Posted: October 26, 2017