Glioblastoma MultiformeNAT109NCT03276286
Nativis Voyager for Newly Diagnosed GBM
A study testing Nativis Voyager in people with Glioblastoma Multiforme, run by Nativis, Inc. at 7 sites in United States.
Trial summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Nativis Voyager
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Nov 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- There is pathological evidence of GBM using World Health Organization (WHO) classification.
- Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
- Subject must have at least one measurable lesion per RANO.
- Subject is at least 18 years of age.
- Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
- Subject has life expectancy > 3 months.
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- Subject has adequate organ and marrow function; see note 1.
- Subject able to start treatment at least 28 days from tumor resection surgery.
- Subject has provided signed informed consent.
Who cannot join
- Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Subject is currently being treated with Optune.
- Subject is currently being treated with other investigational agents.
- Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
- Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
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- Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
- Subject has a clinically significant electrolyte abnormality.
- Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
- Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
- Subject is known to be HIV positive.
- Subject is pregnant, nursing or intends to become pregnant during the study period.
- Subject is participating in other potentially confounding investigational research.
- Subject has any condition that at the discretion of the investigator would preclude participation in the study.
- Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cancer Care Collaborative
Austin, Texas, 78705
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
California Cancer Care Associates
Encinitas, California, 92024
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, 06824
John Wayne Cancer Institute @ Providence St Johns Health Center
Santa Monica, California, 90404
Baylor Scott and White Health
Temple, Texas, 98101
Center for Neurosciences
Tucson, Arizona, 85718
About this study
Official title: A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Nativis Voyager
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nativis VoyagerDevice
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
| Study group | Role | What they receive |
|---|---|---|
| Nativis Voyager | Experimental | Nativis Voyager combined with SOC Radiotherapy and temozolomide Receives: Device: Nativis Voyager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events (Safety)
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
Measured: Through study completion, average of 1 year
Secondary outcomes (2)
Clinical Utility PFS
Progression Free Survival
Measured: 6 months
Clinical Utility OS
Overall Survival
Measured: Through patient completion, expected average 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start10 Nov 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nativis Voyager combined with standard radiotherapy and temozolomide
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nativis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Morgan Murray, PhD, Study chair, Nativis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276286
- Sponsor's protocol ID
- NAT109
- Acronym
- NAT109
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2017
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT03276286
- Acronym / sponsor ID
- NAT109 / NAT109
- Conditions
- Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nativis, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nativis Voyager combined with standard radiotherapy and temozolomide
| Arm | Type | Receives |
|---|---|---|
| Nativis Voyager | Experimental | Device: Nativis VoyagerNativis Voyager combined with SOC Radiotherapy and temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- There is pathological evidence of GBM using World Health Organization (WHO) classification.
- Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
- Subject must have at least one measurable lesion per RANO.
- Subject is at least 18 years of age.
- Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
Key exclusion criteria (15 listed)
- Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Subject is currently being treated with Optune.
- Subject is currently being treated with other investigational agents.
- Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
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 |
|---|---|---|
| Nativis VoyagerNativis Voyager treatment combined with standard of care radiotherapy and temozolomide | Device | Nativis Voyager |
Primary outcome
Treatment-related Adverse Events (Safety)
Time frame: Through study completion, average of 1 year
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
2 secondary outcomes
Clinical Utility PFS
Time frame: 6 months
Clinical Utility OS
Time frame: Through patient completion, expected average 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Donna Morgan Murray, PhD study chair
Nativis, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nativis Voyager in people with Glioblastoma Multiforme, run by Nativis, Inc. at 7 sites 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 9 inclusion and 15 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment-related Adverse Events (Safety) (time frame: Through study completion, average of 1 year). 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 2 Feb 2023.