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Pioglitazone in Thyroid Cancers

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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
Enrollment 1

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Tumor Response (Change)
Hide Description Response is measured by change in Tumor size (cm)
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: cm
Baseline 6.0
24 weeks 3.9
2.Secondary Outcome
Title Change in Serum Thyroglobulin
Hide Description Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: ng/mL
Baseline 1974
24 weeks 49.4
3.Secondary Outcome
Title Toxicity
Hide Description Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness).
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: serious adverse events
0
4.Other Pre-specified Outcome
Title Biomarkers
Hide Description Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis.
Time Frame 24 weeks
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Sensitization to Radioiodine Therapy
Hide Description Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study.
Time Frame 24 weeks
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Lipid Accumulation in Tumor
Hide Description Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
Time Frame 24 weeks
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Pioglitazone Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
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
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