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Trial record 2 of 72 for:    oral premalignant lesions

Pioglitazone for Oral Premalignant Lesions

This study has been terminated.
(Due to slow accrual.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00951379
First received: July 31, 2009
Last updated: March 29, 2016
Last verified: June 2014
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Oral Leukoplakia
Interventions: Drug: Pioglitazone hydrochloride
Other: placebo
Other: laboratory biomarker analysis

  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
Recruitment Period: first participant accrued July 12, 2010 and the last participant accrued on September 10, 2013. Recruitment done in medical clinic settings across the United States, at the European Institute of Oncology in Milan, Italy, and at the BC Cancer Center, Vancouver, British Columbia, Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 99 participants screened during recruitment phase, 47 participants failed screening and were excluded from the trial before assignment to groups. Due to slow accrual, the study was terminated in September 2013.

Reporting Groups
  Description
Arm I (Pioglitazone Hydrochloride) Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
Arm II (Placebo) Three (3) placebo capsules by mouth once daily for 24 weeks

Participant Flow:   Overall Study
    Arm I (Pioglitazone Hydrochloride)     Arm II (Placebo)  
STARTED     27     25  
COMPLETED     21     23  
NOT COMPLETED     6     2  
Adverse Event                 4                 1  
Withdrawal by Subject                 1                 0  
Noncompliance                 1                 0  
Disease Progression                 0                 1  



  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
Arm I (Pioglitazone Hydrochloride) Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
Arm II (Placebo) Three (3) placebo capsules by mouth once daily for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Arm I (Pioglitazone Hydrochloride)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  27     25     52  
Age  
[units: years]
Mean (Standard Deviation)
  59.9  (8.3)     59.0  (10.3)     59.5  (9.2)  
Gender  
[units: participants]
     
Female     16     12     28  
Male     11     13     24  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     25     24     49  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     25     24     49  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     23     22     45  
Italy     4     3     7  
Alcohol Use at Baseline [1]
[units: participants]
     
Heavy     2     3     5  
Light     17     17     34  
Non-Drinker     8     5     13  
Smoking Use at Baseline  
[units: participants]
     
Current     6     6     12  
Former     12     7     19  
Never     9     12     21  
[1] Heavy drinkers are participants who drank every day; Light drinkers are participants who drank on some days; Non-drinkers are former drinkers or those who never drank alcohol.



  Outcome Measures
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1.  Primary:   Overall Response <Clinical and Histologic Response Defined as 50% or Greater Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia>   [ Time Frame: Response assessed at Week 24 ±1 Week ]

2.  Primary:   Dichotomized Histologic Response (HR): Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia   [ Time Frame: Response assessed at Week 24 ±1 Week ]

3.  Primary:   Dichotomized Clinical Response: Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia   [ Time Frame: Response assessed at Week 24 ±1 Week ]

4.  Secondary:   Number of Participants With >5.0 mg/L in Level of C-reactive Protein in Plasma   [ Time Frame: Baseline to end of study, 24 weeks ]

5.  Secondary:   Number of Participants With Level of C-reactive Protein in Plasma Decrease From >5.0 mg/L to <= 5.0 mg/L From Baseline to End of Study   [ Time Frame: Baseline to end of study, 24 weeks ]

6.  Secondary:   Number of Participant With Clinical Response by Baseline Characteristics: Tobacco Use   [ Time Frame: Up to 26 weeks ]

7.  Secondary:   Number of Participant With Clinical Response by Baseline Characteristics: Alcohol Use   [ Time Frame: Up to 26 weeks ]

8.  Secondary:   Number of Participants Affected by Adverse Events Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0)   [ Time Frame: Up to 26 weeks ]

9.  Secondary:   Biomarker Measurements at Scheduled Visits: Tissue Levels of Cyclin D1   [ Time Frame: Baseline to end of study, 24 weeks ]

10.  Secondary:   Biomarker Measurements at Scheduled Visits: Tissue Levels of Ki-67   [ Time Frame: Baseline to end of study, 24 weeks ]

11.  Secondary:   Biomarker Measurements at Scheduled Visits: Tissue Levels of p21   [ Time Frame: Baseline to end of study, 24 weeks ]

12.  Secondary:   Biomarker Measurements at Scheduled Visits: Tissue Levels of B-cell Lymphoma 2 (Bcl2)   [ Time Frame: Baseline to end of study, 24 weeks ]

13.  Secondary:   Biomarker Measurements at Scheduled Visits: Tissue Levels of PPARG Nucleus and PPARG Cytoplasm   [ Time Frame: Baseline to end of study, 24 weeks ]


  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 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: University of Texas MD Anderson Phase I/II Prevention Consortium
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00951379     History of Changes
Other Study ID Numbers: NCI-2012-03152
NCI-2012-03152 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UWI H-2009-0106
MDA-2009-0339 ( Other Identifier: MD Anderson Cancer Center (MDACC) )
INC07-10-01 ( Other Identifier: DCP )
N01CN35159 ( US NIH Grant/Contract Award Number )
N01CN35153 ( US NIH Grant/Contract Award Number )
P30CA016672 ( US NIH Grant/Contract Award Number )
Study First Received: July 31, 2009
Results First Received: October 20, 2015
Last Updated: March 29, 2016
Health Authority: United States: Food and Drug Administration