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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02296580




Registration number
NCT02296580
Ethics application status
Date submitted
18/11/2014
Date registered
20/11/2014
Date last updated
2/02/2023

Titles & IDs
Public title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Scientific title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Secondary ID [1] 0 0
NAT-101
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 - Nativis Voyager RFE Therapy

Experimental: Nativis Voyager RFE Therapy - Subjects will be treated with Nativis Voyager therapy until tumor progression.


Treatment: Devices: Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of any adverse events associated with the investigational therapy.
Timepoint [1] 0 0
Through one month following investigational treatment
Secondary outcome [1] 0 0
Clinical Utility: PFS
Timepoint [1] 0 0
Six months
Secondary outcome [2] 0 0
Clinical Utility: OS
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
* 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.
* Subject is at least 18 years of age.
* Subject has a KPS = 60.
* Subject has adequate organ and marrow function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has received bevacizumab (Avastin).
* Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
* Subject is currently being treated with other investigational agents.
* Subject has received other investigational therapy within the last 28 days.
* Subject has received surgery within the last four weeks.
* Subject is within 12 weeks of completion of radiation.
* Subject has an active implantable or other electromagnetic device.
* Subject has a metal implant, including a programmable shunt, 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 course of the study.

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
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2021
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington

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 first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.
Trial website
https://clinicaltrials.gov/study/NCT02296580
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/NCT02296580