Trial Outcomes & Findings for A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract (NCT NCT00894413)
NCT ID: NCT00894413
Last Updated: 2019-06-11
Results Overview
Median fold-change in immune response of T-cell expansion, delayed-type hypersensitivity reactions, CD4/CD69, CD8/CD69. A positive value indicates an increase in immune response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Change from baseline to up to 14 days post-intervention
Results posted on
2019-06-11
Participant Flow
5 subjects were screen failures
Participant milestones
| Measure |
Placebo
Placebo Pill: Placebo
|
Tadalafil
Tadalafil: 20 mg once daily for 10 - 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
25
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Pill: Placebo
|
Tadalafil
Tadalafil: 20 mg once daily for 10 - 14 days
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Data was not collected in 1/17 participants from tadalafil arm
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Placebo Pill: Placebo
|
Tadalafil
n=17 Participants
Tadalafil: 20 mg once daily for 10 - 14 days
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 6 • n=15 Participants
|
60 years
STANDARD_DEVIATION 15 • n=17 Participants
|
58 years
STANDARD_DEVIATION 12 • n=32 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=15 Participants
|
16 Participants
n=17 Participants
|
29 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=15 Participants
|
14 Participants
n=17 Participants
|
27 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
Black/other
|
2 Participants
n=15 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
17 Participants
n=17 Participants
|
32 Participants
n=32 Participants
|
|
Tobacco exposure
Never
|
8 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
2 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
10 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Tobacco exposure
Ever
|
7 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
14 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
21 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Ethanol (ETOH) Exposure
Never
|
6 Participants
n=13 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
4 Participants
n=14 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
10 Participants
n=27 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
|
Ethanol (ETOH) Exposure
Ever
|
7 Participants
n=13 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
10 Participants
n=14 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
17 Participants
n=27 Participants • Data was not collected in 2/15 participants from the placebo arm and 3/17 participants from the tadalafil arm
|
|
Site of Squamous Cell Carcinoma
Hypopharynx/larynx
|
1 Participants
n=15 Participants
|
6 Participants
n=17 Participants
|
7 Participants
n=32 Participants
|
|
Site of Squamous Cell Carcinoma
Oral cavity
|
5 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
7 Participants
n=32 Participants
|
|
Site of Squamous Cell Carcinoma
Oropharynx
|
9 Participants
n=15 Participants
|
6 Participants
n=17 Participants
|
15 Participants
n=32 Participants
|
|
Site of Squamous Cell Carcinoma
Unknown
|
0 Participants
n=15 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=32 Participants
|
|
Clinical stage
Tumor (T) stage : T0/Tx/T1/T2
|
12 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
6 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
18 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Clinical stage
Tumor (T) stage : T3/T4
|
3 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
10 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
13 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Clinical stage
Node (N) stage : N0/N1
|
7 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
7 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
14 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Clinical stage
Node (N) stage : N2/N3
|
8 Participants
n=15 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
9 Participants
n=16 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
17 Participants
n=31 Participants • Data was not collected in 1/17 participants from tadalafil arm
|
|
Human Papilloma Virus (HPV) status
Negative
|
6 Participants
n=15 Participants
|
10 Participants
n=17 Participants
|
16 Participants
n=32 Participants
|
|
Human Papilloma Virus (HPV) status
Positive
|
8 Participants
n=15 Participants
|
5 Participants
n=17 Participants
|
13 Participants
n=32 Participants
|
|
Human Papilloma Virus (HPV) status
Unknown
|
1 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to up to 14 days post-interventionPopulation: Data was not evaluable in 1/15 participants from the placebo group, 2/17 participants in the tadalafil group (for T-cell expansion, CD4/CD69, CD/CD69) and 1/17 for DTH area.
Median fold-change in immune response of T-cell expansion, delayed-type hypersensitivity reactions, CD4/CD69, CD8/CD69. A positive value indicates an increase in immune response.
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo Pill: Placebo
|
Tadalafil
n=16 Participants
Tadalafil: 20 mg once daily for 10 - 14 days
|
|---|---|---|
|
Change in Immune Response After Tadalafil Administration
CD4/CD69
|
0.90 fold change
Interval 0.44 to 3.1
|
1.29 fold change
Interval 0.86 to 3.19
|
|
Change in Immune Response After Tadalafil Administration
CD8/CD69
|
0.93 fold change
Interval 0.56 to 1.57
|
1.14 fold change
Interval 0.94 to 2.88
|
|
Change in Immune Response After Tadalafil Administration
T-cell expansion
|
1.13 fold change
Interval 0.56 to 2.17
|
1.59 fold change
Interval 0.73 to 6.31
|
|
Change in Immune Response After Tadalafil Administration
DTH area
|
1.14 fold change
Interval 0.17 to 230.0
|
4.74 fold change
Interval 0.27 to 80.0
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Tadalafil
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
Placebo Pill: Placebo
|
Tadalafil
n=25 participants at risk
Tadalafil: 20 mg once daily for 10 - 14 days
|
|---|---|---|
|
Gastrointestinal disorders
Chest Pain
|
6.7%
1/15 • Number of events 1 • up to 4 years
|
4.0%
1/25 • Number of events 1 • up to 4 years
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • up to 4 years
|
4.0%
1/25 • up to 4 years
|
Other adverse events
Adverse event data not reported
Additional Information
Zubair Khan, MD
Johns Hopkins University School of Medicine
Phone: 410-955-3157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place