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CompletedLast updated: 12 January 2024

NAT-105: This study will assess the effects of Nativis Voyager therapy in patients with recurrent Glioblastoma (GBM).A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia

Clinical summary

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.

Conditions

This trial is treating patients with Glioblastoma.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18+

Phase

Not applicable

Trial Acronym

NAT-105

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Nativis, Inc.

Scientific Title

A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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