Trial Review

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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
NA
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02296580