Trial Outcomes & Findings for Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma (NCT NCT03450850)
NCT ID: NCT03450850
Last Updated: 2026-02-17
Results Overview
The primary objective is to estimate the proportion of participants showing no evidence of disease progression six months after initiating treatment with the device. Assessment is per RANO (2010) criteria.
COMPLETED
NA
1 participants
6 months
2026-02-17
Participant Flow
Participant milestones
| Measure |
NOVOTTF-200A
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Overall Study
STARTED
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1
|
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Overall Study
COMPLETED
|
1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
Baseline characteristics by cohort
| Measure |
NOVOTTF-200A
n=1 Participants
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Race (NIH/OMB)
Asian
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0 Participants
n=25 Participants
|
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Age, Categorical
<=18 years
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0 Participants
n=25 Participants
|
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=25 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=25 Participants
|
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Sex: Female, Male
Female
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1 Participants
n=25 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=25 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=25 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=25 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
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1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
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Region of Enrollment
United States
|
1 participants
n=25 Participants
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PRIMARY outcome
Timeframe: 6 monthsThe primary objective is to estimate the proportion of participants showing no evidence of disease progression six months after initiating treatment with the device. Assessment is per RANO (2010) criteria.
Outcome measures
| Measure |
NOVOTTF-200A
n=1 Participants
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.
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1 Participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: Refer to the Adverse Events (AEs) section for full list of reported AEs.
All subjects will be evaluated for safety analysis if they receive NOVOTTF-200A. Safety and tolerability of NOVOTTF-200A treatment will be based on the incidence and severity of adverse events and toxicities. Toxicities will be assessed according to the "Common toxicity criteria (CTC), version 4.03". Refer to the Adverse Events (AEs) section for full list of reported AEs.
Outcome measures
| Measure |
NOVOTTF-200A
n=1 Participants
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Number of Participants Who Experience Any Adverse Events Who Received NOVOTTF-200A.
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1 Participants
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SECONDARY outcome
Timeframe: Will be assessed at baseline and every two cycles (at the end of each even-numbered cycle of therapy) until treatment termination, an average of 24 monthsTo determine if the treatment significantly modifies the patient's quality of life we will be using the Functional Assessment of Cancer Therapy (FACT) questionnaires that include the FACT-Brain (FACT-Br), and the FACT-Cognitive Function (FACT-Cog) questionnaires. These will be completed at baseline then every two cycles. Scores of FACT-COG and FACT-Br are combined below at baseline and last cycle of treatment. Scores of FACT-COG and FACT-Br are summed to obtain a total possible scale range of 0 to 272. FACT-Cog (using the Cognitive Impairments subscale) with a score range from 0-72 and FACT-Br with a score range from 0-200. A higher score, means a better quality of life.
Outcome measures
| Measure |
NOVOTTF-200A
n=1 Participants
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Does the Treatment Significantly Modify the Patient's Quality of Life?
Baseline
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239 score
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Does the Treatment Significantly Modify the Patient's Quality of Life?
Last Cycle
|
198 score
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SECONDARY outcome
Timeframe: Assessed at screening.To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
Outcome measures
| Measure |
NOVOTTF-200A
n=1 Participants
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
ATRX
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0 Participants
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Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
TERT promoter
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0 Participants
|
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Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
IDH1
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1 Participants
|
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Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
MGMT
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0 Participants
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Adverse Events
NOVOTTF-200A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NOVOTTF-200A
n=1 participants at risk
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
NOVOTTF-200A: NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
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|---|---|
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Skin and subcutaneous tissue disorders
Scalp Irritation
|
100.0%
1/1 • Number of events 2 • Adverse events were collected following initiation of treatment until 2 months after treatment termination, an average of 24 months.
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Ear and labyrinth disorders
Hearing Difference
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100.0%
1/1 • Number of events 1 • Adverse events were collected following initiation of treatment until 2 months after treatment termination, an average of 24 months.
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General disorders
Flu-like Symptoms
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100.0%
1/1 • Adverse events were collected following initiation of treatment until 2 months after treatment termination, an average of 24 months.
|
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Eye disorders
Conjunctivitis
|
100.0%
1/1 • Adverse events were collected following initiation of treatment until 2 months after treatment termination, an average of 24 months.
|
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Infections and infestations
COVID-19
|
100.0%
1/1 • Adverse events were collected following initiation of treatment until 2 months after treatment termination, an average of 24 months.
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Additional Information
Chao Family Comprehensive Cancer Center, University of California, Irvine
Chao Family Comprehensive Cancer Center, University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place