Trial Outcomes & Findings for Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma (NCT NCT00841204)
NCT ID: NCT00841204
Last Updated: 2017-12-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-12-26
Participant Flow
Participant milestones
| Measure |
Sulindac
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Baseline characteristics by cohort
| Measure |
Sulindac
n=25 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
45.9 years
STANDARD_DEVIATION 8.59 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 9.24 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Sulindac Concentration in the Nevi (Moles)
|
0.51 µg/g tissue
Standard Deviation 1.05
|
0 µg/g tissue
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi
|
1.38 µg/g tissue
Standard Deviation 2.86
|
0 µg/g tissue
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi
|
0.12 µg/g tissue
Standard Deviation 0.12
|
0 µg/g tissue
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksChange in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component
Outcome measures
| Measure |
Sulindac
n=20 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=21 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Sulindac Effects on Apoptosis in Atypical Nevi
|
3 % of stained cells * intensity score
Interval -8.0 to 32.0
|
-25 % of stained cells * intensity score
Interval -55.0 to -10.0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksChange in VEGF expression in melanocytic junctional component
Outcome measures
| Measure |
Sulindac
n=20 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=21 Participants
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi
|
23 % of stained cells * intensity score
Interval -13.0 to 50.0
|
0 % of stained cells * intensity score
Interval -50.0 to 35.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The correlation between plasma and target tissue sulindac levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Association Between Plasma and Target Tissue Sulindac Levels
|
0.41 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The correlation between plasma and target tissue sulindac sulfone levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Association Between Plasma and Target Tissue Sulindac Sulfone Levels
|
0.13 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The correlation between plasma and target tissue sulindac sulfide levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.
Outcome measures
| Measure |
Sulindac
n=24 Participants
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Association Between Plasma and Target Tissue Sulindac Sulfide Levels
|
0.33 correlation coefficient
|
—
|
Adverse Events
Sulindac
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulindac
n=25 participants at risk
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 participants at risk
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Vasovagal episode
|
4.0%
1/25
|
0.00%
0/25
|
Other adverse events
| Measure |
Sulindac
n=25 participants at risk
Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
|
Placebo
n=25 participants at risk
Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
4/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
2/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Heartburn
|
16.0%
4/25
|
12.0%
3/25
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Prutitus
|
8.0%
2/25
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Other skin disorders
|
8.0%
2/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Stomach pain
|
4.0%
1/25
|
8.0%
2/25
|
|
Immune system disorders
Allergic reaction
|
4.0%
1/25
|
8.0%
2/25
|
|
Infections and infestations
Sinus infection
|
0.00%
0/25
|
8.0%
2/25
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25
|
0.00%
0/25
|
|
Infections and infestations
Other infection
|
16.0%
4/25
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/25
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Extremity/Limb pain
|
0.00%
0/25
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
12.0%
3/25
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal congestion
|
8.0%
2/25
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Larynx/Pharynx/Throat pain
|
12.0%
3/25
|
8.0%
2/25
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25
|
8.0%
2/25
|
|
Reproductive system and breast disorders
Uterus pain
|
16.0%
4/25
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
16.0%
4/25
|
12.0%
3/25
|
|
General disorders
Fatigue
|
12.0%
3/25
|
12.0%
3/25
|
|
General disorders
Fever
|
8.0%
2/25
|
0.00%
0/25
|
|
Nervous system disorders
Headache
|
56.0%
14/25
|
56.0%
14/25
|
|
General disorders
Flu-like syndromes
|
20.0%
5/25
|
20.0%
5/25
|
|
General disorders
Other pain
|
20.0%
5/25
|
12.0%
3/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60