Astrocytoma, Grade IIINCT03450850
Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
A study testing NOVOTTF-200A in people with Astrocytoma, Grade III, run by Daniela A. Bota at 1 site in United States.
Trial summary
This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Astrocytoma, Grade III
- What is being tested?
- NOVOTTF-200A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted.
- Males and females of age ≥18 years at the time of the signing of the informed consent document.
- All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR).
- Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
- No prior treatment with BEV or any anti-angiogenesis agents.
- At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
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- All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below).
- Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions and/or growth factor support may be used at the discretion of the Investigator during Screening):
- Hemoglobin ≥9 g/dL.
- Absolute neutrophil count (ANC) ≥1.5 × 109/L.
- Platelet count ≥100 × 109/L.
- Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's disease is documented.
- Aspartate transaminase (AST) ≤ 2.5 ULN.
- Serum creatinine ≤1.5 × ULN.
- Karnofsky Performance Status (KPS) score ≥70%.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO).
- Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.)
- Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment.
- Pregnancy or breastfeeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state.
- Known previous/current malignancy requiring treatment within ≤ 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma.
- Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
Official title: Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma
This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.
Read the detailed description
Primary Objective:
The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)
Secondary Objectives:
- To evaluate the safety of NOVOTTF-200A in the subject population.
- To evaluate efficacy of NOVOTTF-200A in the subject population.
- To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
- To determine if the treatment significantly modifies the patient's quality of life. Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:
- FACT-Brain (FACT-Br)
- FACT-Cognitive Function (FACT-Cog)
Exploratory Objectives:
- To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis) confers a better response to NovoTTF.
- To determine if the in vitro sensitivity of the glioma cells derived from patient specimens before and after the NOVOTTF-200A treatment correlates with the patient's response to treatment.
- Conditions
- Astrocytoma, Grade III
- Being tested
- NOVOTTF-200A
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOTTF-200ADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NOVOTTF-200A | Other | NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma Receives: Device: NOVOTTF-200A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.
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.
Measured: 6 months
Secondary outcomes (3)
Number of Participants Who Experience Any Adverse Events Who Received NOVOTTF-200A.
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.
Measured: 1 year
Does the Treatment Significantly Modify the Patient's Quality of Life?
To 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.
Measured: 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 months
Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
Measured: Assessed at screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start21 May 2020
- Primary completion7 Sep 2023
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Astrocytoma, Grade IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela A. Bota
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor-investigator, Daniela A. Bota, University of California, Irvine
- Investigators
- Daniela Bota, MD, Principal investigator, UC Irvine Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450850
- Sponsor's protocol ID
- 20174031
- Other IDs
- UCI 16-56
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2018
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma
- ClinicalTrials.gov ID
- NCT03450850
- Acronym / sponsor ID
- 20174031
- Conditions
- Astrocytoma, Grade III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Daniela A. BotaUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 21 May 2020 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.
Detailed description
Primary Objective:
The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)
Secondary Objectives:
- To evaluate the safety of NOVOTTF-200A in the subject population.
- To evaluate efficacy of NOVOTTF-200A in the subject population.
- To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
- To determine if the treatment significantly modifies the patient's quality of life. Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:
- FACT-Brain (FACT-Br)
- FACT-Cognitive Function (FACT-Cog)
Exploratory Objectives:
- To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis) confers a better response to NovoTTF.
- To determine if the in vitro sensitivity of the glioma cells derived from patient specimens before and after the NOVOTTF-200A treatment correlates with the patient's response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVOTTF-200A | Other | Device: NOVOTTF-200ANOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted.
- Males and females of age ≥18 years at the time of the signing of the informed consent document.
- All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR).
- Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
- No prior treatment with BEV or any anti-angiogenesis agents.
Key exclusion criteria (8 listed)
- The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO).
- Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.)
- Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment.
- Pregnancy or breastfeeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVOTTF-200ANOVOTTF-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. | Device | NOVOTTF-200A |
Primary outcome
Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.
Time frame: 6 months
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.
3 secondary outcomes
Number of Participants Who Experience Any Adverse Events Who Received NOVOTTF-200A.
Time frame: 1 year
Does the Treatment Significantly Modify the Patient's Quality of Life?
Time frame: 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 months
Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
Time frame: Assessed at screening.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Bota, MD principal investigator
UC Irvine Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVOTTF-200A in people with Astrocytoma, Grade III, run by Daniela A. Bota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.