Trial Outcomes & Findings for Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity (NCT NCT01296815)
NCT ID: NCT01296815
Last Updated: 2015-07-27
Results Overview
Complete response will be assessed according to RECIST criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
12 months
Results posted on
2015-07-27
Participant Flow
Participant milestones
| Measure |
HAART
Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
|
HAART+ Bevacizumab Injection
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Baseline characteristics by cohort
| Measure |
HAART
n=7 Participants
Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
|
HAART+ Bevacizumab Injection
n=7 Participants
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
Total
n=14 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
n=5 Participants
|
35 years
n=7 Participants
|
30.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsComplete response will be assessed according to RECIST criteria
Outcome measures
| Measure |
HAART
n=7 Participants
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
HAART+ Bevacizumab Injection
n=7 Participants
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
|---|---|---|
|
Number of Participants With Complete Response
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsAdverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Outcome measures
Outcome data not reported
Adverse Events
HAART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HAART+ Bevacizumab Injection
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HAART
n=7 participants at risk
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
HAART+ Bevacizumab Injection
n=7 participants at risk
Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Fever
|
0.00%
0/7 • 1 year
Toxicity was graded and recorded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table)
|
14.3%
1/7 • Number of events 1 • 1 year
Toxicity was graded and recorded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table)
|
Other adverse events
Adverse event data not reported
Additional Information
Gustavo Reyes-Teran
Centro de Investigación en. Enfermedades Infecciosas
Phone: 52 55 56667985
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place