Trial Outcomes & Findings for Preventing Squamous Cell Skin Cancer (NCT NCT02347813)
NCT ID: NCT02347813
Last Updated: 2020-06-23
Results Overview
Squamous Cell Carcinomas were counted by visual inspection of the all skin on the body.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2020-06-23
Participant Flow
Thirteen subjects consented, 1 subject screen failed, 2 subjects from the Delayed Intervention Arm were Early Terminations, 2 subjects from the Immediate Intervention Arm were Early Terminations, resulting in 4 subjects being randomized in to the Delayed Intervention Arm and 4 subjects being randomized in to the Immediate Intervention arm.
Participant milestones
| Measure |
No Intervention, Then Pioglitazone
After enrollment, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. Then they will begin the pioglitazone regimen for 24 more weeks, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
Pioglitazone, Then no Intervention
Subjects will begin the 24 week pioglitazone regimen immediately after enrollment, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. After 24 weeks of drug, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
First Intervention, 24 Weeks
STARTED
|
6
|
6
|
|
First Intervention, 24 Weeks
COMPLETED
|
4
|
4
|
|
First Intervention, 24 Weeks
NOT COMPLETED
|
2
|
2
|
|
Second Intervention, 24 Weeks
STARTED
|
4
|
4
|
|
Second Intervention, 24 Weeks
COMPLETED
|
4
|
4
|
|
Second Intervention, 24 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
No Intervention, Then Pioglitazone
After enrollment, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. Then they will begin the pioglitazone regimen for 24 more weeks, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
Pioglitazone, Then no Intervention
Subjects will begin the 24 week pioglitazone regimen immediately after enrollment, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. After 24 weeks of drug, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
First Intervention, 24 Weeks
Withdrawal by Subject
|
1
|
1
|
|
First Intervention, 24 Weeks
Adverse Event
|
1
|
1
|
Baseline Characteristics
Preventing Squamous Cell Skin Cancer
Baseline characteristics by cohort
| Measure |
No Intervention, Then Pioglitazone
n=6 Participants
After enrollment, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. Then they will begin the pioglitazone regimen for 24 more weeks, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
Pioglitazone, Then no Intervention
n=6 Participants
Subjects will begin the 24 week pioglitazone regimen immediately after enrollment, during which time skin cancer tumors will be observed and appropriately treated as per standard of care. After 24 weeks of drug, subjects will be observed for 24 weeks for skin cancer tumors. Tumors will be appropriately treated as per standard of care. There was no washout period.
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearSquamous Cell Carcinomas were counted by visual inspection of the all skin on the body.
Outcome measures
| Measure |
No Intervention
n=8 Participants
Standard of care
|
Pioglitazone
n=8 Participants
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
Mean Number of Squamous Cell Carcinomas
|
0.75 # of squamous cell carcinomas
Standard Deviation 0.71
|
1.00 # of squamous cell carcinomas
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 1 yearCancers were counted by visual inspection of the all skin on the body. Patients were inspected for the following cancer types: squamous cell carcinoma, basal cell carcinoma and melanoma.
Outcome measures
| Measure |
No Intervention
n=8 Participants
Standard of care
|
Pioglitazone
n=8 Participants
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
Mean Number of Other Skin Cancers
|
1 # of other carcinomas
Standard Deviation 0
|
0 # of other carcinomas
Standard Deviation 0
|
Adverse Events
No Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Pioglitazone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Intervention
n=12 participants at risk
Standard of Care
|
Pioglitazone
n=12 participants at risk
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Metastatic squamous cell carcinoma
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
Other adverse events
| Measure |
No Intervention
n=12 participants at risk
Standard of Care
|
Pioglitazone
n=12 participants at risk
Pioglitazone: 15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place