Trial Outcomes & Findings for Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP) (NCT NCT01020747)
NCT ID: NCT01020747
Last Updated: 2012-12-20
Results Overview
Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2012-12-20
Participant Flow
Participant milestones
| Measure |
Group Avastin
Subjects received Avastin in the more diseased vocal fold and saline in the other.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Group Avastin
Subjects received Avastin in the more diseased vocal fold and saline in the other.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)
Baseline characteristics by cohort
| Measure |
Group Avastin
n=20 Participants
Subjects received Avastin in the more diseased vocal fold and saline in the other.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
47.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All subjects were analyzed.
Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.
Outcome measures
| Measure |
Bevacizumab Treated Vocal Fold
n=20 Participants
Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
|
Untreated Vocal Fold
n=20 Participants
Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
|
|---|---|---|
|
The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.
|
85.3 total percentage change
Standard Deviation 68.6
|
225.3 total percentage change
Standard Deviation 191.1
|
Adverse Events
Group Avastin
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group Avastin
n=20 participants at risk
Subjects received Avastin in the more diseased vocal fold and saline in the other.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aguesia
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
cough/URI
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Musculoskeletal and connective tissue disorders
disk herniation
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
Diminished voice volume
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
drainage and congestion
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
dysphagia
|
10.0%
2/20 • Number of events 2 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Eye disorders
eye twitching
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Infections and infestations
flu-like symptoms
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
General disorders
headache
|
10.0%
2/20 • Number of events 2 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
higher pitch
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
100.0%
20/20 • Number of events 20 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Injury, poisoning and procedural complications
oversedation
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Skin and subcutaneous tissue disorders
poison ivy rash
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Skin and subcutaneous tissue disorders
toe (right) cellulitis
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
Injury, poisoning and procedural complications
tongue numbness
|
10.0%
2/20 • Number of events 2 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
|
General disorders
tooth ache
|
5.0%
1/20 • Number of events 1 • The main treatment period lasted 6 months for each subject. Adverse events were captured for all subjects for a period of 26 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place