Trial Outcomes & Findings for Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM (NCT NCT01811498)
NCT ID: NCT01811498
Last Updated: 2024-01-30
Results Overview
PFS was defined from the date of the first dose of SIACI Bevacizumab until first documentation of disease pro- gression, or death from any cause, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Percent of Participants with 6 Month Progression-Free Survival
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
SIACI of Bevacizumab
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
Baseline characteristics by cohort
| Measure |
SIACI of Bevacizumab
n=23 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Percent of Participants with 6 Month Progression-Free SurvivalPFS was defined from the date of the first dose of SIACI Bevacizumab until first documentation of disease pro- gression, or death from any cause, whichever occurred first.
Outcome measures
| Measure |
SIACI of Bevacizumab
n=23 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
Progression-free Survival (PFS)
|
91.3 percentage of participants
Interval 69.5 to 97.8
|
PRIMARY outcome
Timeframe: 8 months, and until death of any cause, up to approximately 8 yearsOverall Survival was defined from the date of the first dose of SIACI Bevacizumab until death from any cause.
Outcome measures
| Measure |
SIACI of Bevacizumab
n=23 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
Overall Survival (OS)
|
23.1 months
Interval 12.2 to 36.9
|
SECONDARY outcome
Timeframe: 30 days post treatmentPopulation: Total of 23 participants some who had multiple AE's therefore the adverse events number exceeds particpants.
The descriptive frequency of subjects experiencing toxicities will be tabulated.
Outcome measures
| Measure |
SIACI of Bevacizumab
n=23 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
Number of Adverse Events
Grade 1 Adverse Events
|
31 Adverse events
|
|
Number of Adverse Events
Grade 2 Adverse Events
|
15 Adverse events
|
|
Number of Adverse Events
Grade 3 Adverse Events
|
12 Adverse events
|
Adverse Events
SIACI of Bevacizumab
Serious events: 0 serious events
Other events: 16 other events
Deaths: 16 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SIACI of Bevacizumab
n=23 participants at risk
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Bevacizumab
|
|---|---|
|
General disorders
Fatigue
|
30.4%
7/23 • Number of events 7 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
General disorders
Anxiety
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
General disorders
Headache
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Brain Hemorrhage
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Unilateral Weakness
|
17.4%
4/23 • Number of events 4 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Aphasia
|
26.1%
6/23 • Number of events 6 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Seizure
|
30.4%
7/23 • Number of events 7 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Paresthesia
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Nervous system disorders
Memory Impairment
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Gastrointestinal disorders
Appetite Loss
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Gastrointestinal disorders
Gastric Reflux
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Vascular disorders
Vasospasm
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Vascular disorders
Thrombocytopenia
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Vascular disorders
Deep Vein Thrombosis
|
13.0%
3/23 • Number of events 3 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Vascular disorders
Pulmonary Embolus
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Vascular disorders
Leukopenia
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Skin and subcutaneous tissue disorders
Scalp Tenderness
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Metabolism and nutrition disorders
Creatinine Increase
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Metabolism and nutrition disorders
GGT Increase
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.3%
1/23 • Number of events 1 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2 • Adverse events were assessed up to 30 days post treatment (approximately 8 months). All-Cause Mortality was from first dose until death, approximately 8 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place