Trial Outcomes & Findings for A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract (NCT NCT01697800)
NCT ID: NCT01697800
Last Updated: 2020-02-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 120-150 Days
Results posted on
2020-02-28
Participant Flow
Participant milestones
| Measure |
Placebo
Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
Tadalafil
Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
25
|
|
Overall Study
COMPLETED
|
15
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
Tadalafil
Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Patients received placebo capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
Tadalafil
n=25 Participants
Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-99 years
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 120-150 DaysPopulation: Blood samples were collected. However, the samples were not analyzed and hence no data were generated.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tadalafil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
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