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Trial record 1 of 1 for:    Nativis 109
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Nativis Voyager for Newly Diagnosed GBM (NAT109)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Nativis, Inc.

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Device: Nativis Voyager Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Official Title: A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nativis Voyager
Nativis Voyager combined with SOC Radiotherapy and temozolomide
Device: Nativis Voyager
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical Utility PFS [ Time Frame: 6 months ]
    Progression Free Survival

  2. Clinical Utility OS [ Time Frame: Through patient completion, expected average 8 months ]
    Overall Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276286

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United States, Arizona
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, California
California Cancer Care Associates
Encinitas, California, United States, 92024
John Wayne Cancer Institute @ Providence St Johns Health Center
Santa Monica, California, United States, 90404
United States, Connecticut
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States, 06824
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
United States, Texas
Cancer Care Collaborative
Austin, Texas, United States, 78705
Baylor Scott and White Health
Temple, Texas, United States, 98101
Sponsors and Collaborators
Nativis, Inc.
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Study Chair: Donna Morgan Murray, PhD Nativis, Inc.
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Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT03276286    
Other Study ID Numbers: NAT109
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue