Trial Outcomes & Findings for NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma (NCT NCT01894061)
NCT ID: NCT01894061
Last Updated: 2025-02-17
Results Overview
Efficacy of therapy as measured by percent of participants with (PFS6). This trial will be considered successful if at least 20% of participants achieve PFS at 6 months. Disease progression is defined by RANO criteria. In cases where the RANO criteria cannot be applied, progression should be based on unequivocal evidence of progressive disease sufficient to require a change in therapy. The Modified RANO criteria are a set of guidelines for evaluating treatment response clinical trials. Modified RANO Response Criteria include levels of response including Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease.
COMPLETED
PHASE2
25 participants
6 months
2025-02-17
Participant Flow
Participant milestones
| Measure |
Bevacizumab and NovoTTF-100A
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bevacizumab and NovoTTF-100A
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Overall Study
Screen failure
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Bevacizumab and NovoTTF-100A
n=25 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Age, Customized
10-19 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
unknown
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants eligible for analysis (completed study)
Efficacy of therapy as measured by percent of participants with (PFS6). This trial will be considered successful if at least 20% of participants achieve PFS at 6 months. Disease progression is defined by RANO criteria. In cases where the RANO criteria cannot be applied, progression should be based on unequivocal evidence of progressive disease sufficient to require a change in therapy. The Modified RANO criteria are a set of guidelines for evaluating treatment response clinical trials. Modified RANO Response Criteria include levels of response including Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=23 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Percent of Participants With 6-month Progression-free Survival (PFS6)
|
33 percent of participants
Interval 9.0 to 60.0
|
SECONDARY outcome
Timeframe: 30 days after treatment completion through study completion, an average of 5 years, 9 monthsPopulation: Only 16 of the 25 participants were analyzed because 9 participants were not evaluable.
ORR as defined by the modified Response Assessment in Neuro-Oncology (RANO) criteria.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=16 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Objective Response Rate (ORR) Based on RANO Criteria
Complete Response
|
1 Participants
|
|
Objective Response Rate (ORR) Based on RANO Criteria
Partial Response
|
3 Participants
|
|
Objective Response Rate (ORR) Based on RANO Criteria
Stable Disease
|
6 Participants
|
|
Objective Response Rate (ORR) Based on RANO Criteria
Progressive Disease
|
6 Participants
|
SECONDARY outcome
Timeframe: 5 years, 9 monthsPopulation: All participants enrolled in study
Number of participants experiencing grade 3 or 4 toxicities related to therapy combination per by CTCAE version 4.0.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=25 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Number of Participants Experiencing Grade 3/4 Toxicities Related to Therapy Combination Per by CTCAE Version 4.0.
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)Population: Participants eligible for analysis (completed study)
Median overall survival (OS) in months
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=23 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Median Overall Survival
|
10.5 months
Interval 8.2 to 14.9
|
SECONDARY outcome
Timeframe: 30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)Population: Participants eligible for analysis (completed study)
Median time to progression by Kaplan Meier methodology. Disease progression is defined by RANO criteria. In cases where the RANO criteria cannot be applied, progression should be based on unequivocal evidence of progressive disease sufficient to require a change in therapy. The Modified RANO criteria are a set of guidelines for evaluating treatment response clinical trials. Modified RANO Response Criteria include levels of response including Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=23 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Median Time-to-progression
|
4.1 months
Interval 3.6 to 9.5
|
SECONDARY outcome
Timeframe: 30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)Population: Only 2 participants reached reliable NCF change.
Time to reliable change in NCF by Kaplan Meier methodology. Memory, verbal fluency, visual-motor speed, executive function and motor dexterity tests will be administered. NCF testing involves standardized psychometric instruments that are sensitive to the neurotoxic effects of cancer treatment in brain tumor clinical trials.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=2 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Time to Reliable Change in Neurocognitive Function (NCF)
|
1.9 months
Interval 0.14 to 3.7
|
SECONDARY outcome
Timeframe: Baseline, 30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)Population: Only 5 participants had QOL change from baseline.
Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) is a 54-item questionnaire that has four areas of cumulative measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-Br total score ranges between 0 and 76. The higher the score, the better the quality of life.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=5 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Change From Baseline in Quality of Life (QOL) as Measured by FACT-BR Score
|
6 scores on a scale
Interval -2.0 to 7.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants eligible for analysis (completed study)
Efficacy of therapy as measured by percent of participants with 12-month PFS. Disease progression is defined by modified RANO criteria. In cases where the modified RANO criteria cannot be applied, progression should be based on unequivocal evidence of progressive disease sufficient to require a change in therapy. The Modified RANO criteria are a set of guidelines for evaluating treatment response clinical trials. Modified RANO Response Criteria include levels of response including Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease.
Outcome measures
| Measure |
Bevacizumab and NovoTTF-100A
n=23 Participants
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Percent of Participants With 12-month Progression-free Survival
|
19 percent of participants
Interval 8.0 to 46.0
|
Adverse Events
Bevacizumab and NovoTTF-100A
Serious adverse events
| Measure |
Bevacizumab and NovoTTF-100A
n=25 participants at risk
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
1/25 • Number of events 1 • 5 years, 9 months
|
|
Nervous system disorders
Seizure
|
8.0%
2/25 • Number of events 3 • 5 years, 9 months
|
|
Nervous system disorders
Stroke
|
4.0%
1/25 • Number of events 1 • 5 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • 5 years, 9 months
|
Other adverse events
| Measure |
Bevacizumab and NovoTTF-100A
n=25 participants at risk
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-l00A: NovoTTF-100A will be worn continuously.
Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
Gastrointestinal disorders
Mucostis oral
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
General disorders
Edema limbs
|
32.0%
8/25 • Number of events 9 • 5 years, 9 months
|
|
General disorders
Fatigue
|
36.0%
9/25 • Number of events 12 • 5 years, 9 months
|
|
General disorders
Gaid disturbance
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
General disorders
Irritability
|
8.0%
2/25 • Number of events 3 • 5 years, 9 months
|
|
General disorders
Pain
|
8.0%
2/25 • Number of events 3 • 5 years, 9 months
|
|
Infections and infestations
Bronchial infection
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Injury, poisoning and procedural complications
Bruising
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
Investigations
Alanine amiotransferase increased
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Investigations
Lymphocyte count decreased
|
12.0%
3/25 • Number of events 4 • 5 years, 9 months
|
|
Investigations
Platelet count decreased
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Nervous system disorders
Cognitive disturbance
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Nervous system disorders
Dysphasia
|
16.0%
4/25 • Number of events 4 • 5 years, 9 months
|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Number of events 5 • 5 years, 9 months
|
|
Nervous system disorders
Memory imparement
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
Nervous system disorders
Paresthesia
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Nervous system disorders
Seizure
|
12.0%
3/25 • Number of events 4 • 5 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.0%
3/25 • Number of events 3 • 5 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.0%
6/25 • Number of events 6 • 5 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.0%
3/25 • Number of events 4 • 5 years, 9 months
|
|
Vascular disorders
Hypertension
|
40.0%
10/25 • Number of events 24 • 5 years, 9 months
|
|
Vascular disorders
Throboembolic event
|
8.0%
2/25 • Number of events 2 • 5 years, 9 months
|
Additional Information
Dr. David Peereboom
Cleveland Clinic, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place