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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02507102




Registration number
NCT02507102
Ethics application status
Date submitted
22/07/2015
Date registered
23/07/2015
Date last updated
30/03/2018

Titles & IDs
Public title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Scientific title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Secondary ID [1] 0 0
NAT-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Voyager

Experimental: Investigational Voyager Therapy - Investigational treatment with Voyager Therapy


Treatment: Devices: Voyager
Non-invasive RFE therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Tumor Response
Timepoint [2] 0 0
2 months
Secondary outcome [1] 0 0
Overall survival at six months compared with historical response
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Progression free survival
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
1. Subject has histologically confirmed diagnosis of GBM.
2. Subject has failed or intolerant to radiotherapy.
3. Subjects has failed or intolerant to temozolomide therapy.
4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
5. Subject is at least 18 years of age.
6. Subject has a KPS = 60.
7. Subject has adequate organ and marrow function.
8. Subject has provided signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has life expectancy less than eight weeks
2. Subject has received other investigational therapy within the last 28 days.
3. Subject has received surgery within the last two weeks or not fully from prior surgery.
4. Subject has a clinically significant electrolyte abnormality.
5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
7. Subject is known to be HIV positive.
8. Subject is pregnant, nursing or intends to become pregnant during the study period.
9. Subject is participating in other investigational research.
10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2018
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nativis, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02507102
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donna Morgan Murray, PhD
Address 0 0
Nativis, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02507102