Glioblastoma MultiformeNCT02507102
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
A study testing Voyager in people with Glioblastoma Multiforme, run by Nativis, Inc. at 1 site in Australia.
Trial summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated. 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?
- Voyager
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2015to 26 Mar 2018
- 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
- Subject has histologically confirmed diagnosis of GBM.
- Subject has failed or intolerant to radiotherapy.
- Subjects has failed or intolerant to temozolomide therapy.
- Subject has progressive disease with at least one measureable lesion on MRI or CT.
- Subject is at least 18 years of age.
- Subject has a KPS ≥ 60.
- Subject has adequate organ and marrow function.
- Subject has provided signed informed consent.
Who cannot join
- Subject has life expectancy less than eight weeks
- Subject has received other investigational therapy within the last 28 days.
- Subject has received surgery within the last two weeks or not fully from prior surgery.
- Subject has a clinically significant electrolyte abnormality.
- Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
- Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
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- 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 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
1 site in 1 country.
About this study
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Voyager
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoyagerDevice
Non-invasive RFE therapy
| Study group | Role | What they receive |
|---|---|---|
| Investigational Voyager Therapy | Experimental | Investigational treatment with Voyager Therapy Receives: Device: Voyager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Measured: 6 months
Tumor Response
Tumor imaging response (RANO) at two months of therapy.
Measured: 2 months
Secondary outcomes (2)
Overall survival at six months compared with historical response
Measured: 6 months
Progression free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completion26 Mar 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nativis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Morgan Murray, PhD, Study director, Nativis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507102
- Sponsor's protocol ID
- NAT-105
- Status last verified
- Mar 2018
- First submitted
- 22 Jul 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. 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 Recurrent Glioblastoma Multiforme (GBM) in Australia
- ClinicalTrials.gov ID
- NCT02507102
- Acronym / sponsor ID
- NAT-105
- Conditions
- Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nativis, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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 with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Voyager Therapy | Experimental | Device: VoyagerInvestigational treatment with Voyager Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has histologically confirmed diagnosis of GBM.
- Subject has failed or intolerant to radiotherapy.
- Subjects has failed or intolerant to temozolomide therapy.
- Subject has progressive disease with at least one measureable lesion on MRI or CT.
- Subject is at least 18 years of age.
Key exclusion criteria (11 listed)
- Subject has life expectancy less than eight weeks
- Subject has received other investigational therapy within the last 28 days.
- Subject has received surgery within the last two weeks or not fully from prior surgery.
- Subject has a clinically significant electrolyte abnormality.
- Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
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 |
|---|---|---|
| VoyagerNon-invasive RFE therapy | Device | Investigational Voyager Therapy |
Primary outcome
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Time frame: 6 months
Tumor Response
Time frame: 2 months
Tumor imaging response (RANO) at two months of therapy.
2 secondary outcomes
Overall survival at six months compared with historical response
Time frame: 6 months
Progression free survival
Time frame: 6 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 30 Mar 2018.
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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 director
Nativis, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voyager in people with Glioblastoma Multiforme, run by Nativis, Inc. at 1 site in Australia.
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 8 inclusion and 11 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 30 Mar 2018. 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 Australia. 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?
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System (time frame: 6 months). The study lists 2 primary outcomes in all. 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 30 Mar 2018.