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Nativis Voyager for Newly Diagnosed GBM (NAT109)

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ClinicalTrials.gov Identifier: NCT03276286
Recruitment Status : Unknown
Verified August 2019 by Nativis, Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 8, 2017
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE November 10, 2017
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • Clinical Utility PFS [ Time Frame: 6 months ]
    Progression Free Survival
  • Clinical Utility OS [ Time Frame: Through patient completion, expected average 8 months ]
    Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nativis Voyager for Newly Diagnosed GBM
Official Title  ICMJE A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Nativis Voyager combined with standard radiotherapy and temozolomide
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE Device: Nativis Voyager
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
Study Arms  ICMJE Experimental: Nativis Voyager
Nativis Voyager combined with SOC Radiotherapy and temozolomide
Intervention: Device: Nativis Voyager
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
37
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2017)
10
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03276286
Other Study ID Numbers  ICMJE NAT109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nativis, Inc.
Study Sponsor  ICMJE Nativis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Donna Morgan Murray, PhD Nativis, Inc.
PRS Account Nativis, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP