Trial Outcomes & Findings for Pioglitazone in Thyroid Cancers (NCT NCT01655719)
NCT ID: NCT01655719
Last Updated: 2017-10-26
Results Overview
Response is measured by change in Tumor size (cm)
COMPLETED
PHASE2
1 participants
Baseline and 24 weeks
2017-10-26
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pioglitazone in Thyroid Cancers
Baseline characteristics by cohort
| Measure |
Pioglitazone Treatment
n=1 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksResponse is measured by change in Tumor size (cm)
Outcome measures
| Measure |
Pioglitazone Treatment
n=1 Participants
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.
|
|---|---|
|
Tumor Response (Change)
Baseline
|
6.0 cm
|
|
Tumor Response (Change)
24 weeks
|
3.9 cm
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksDetermine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
Outcome measures
| Measure |
Pioglitazone Treatment
n=1 Participants
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.
|
|---|---|
|
Change in Serum Thyroglobulin
Baseline
|
1974 ng/mL
|
|
Change in Serum Thyroglobulin
24 weeks
|
49.4 ng/mL
|
SECONDARY outcome
Timeframe: 24 weeksToxicities 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).
Outcome measures
| Measure |
Pioglitazone Treatment
n=1 Participants
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.
|
|---|---|
|
Toxicity
|
0 serious adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksDefine 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksDetermine 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksDetermine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.
Outcome measures
Outcome data not reported
Adverse Events
Pioglitazone Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place