A P1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for Recurrent HGG and Followed by Treatment With Extended-Release 5-FC

Trial Profile

A P1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for Recurrent HGG and Followed by Treatment With Extended-Release 5-FC

Completed
Phase of Trial: Phase I

Latest Information Update: 28 May 2018

At a glance

  • Drugs Vocimagene amiretrorepvec-flucytosine gene therapy (Primary)
  • Indications Glioblastoma; Glioma
  • Focus Adverse reactions
  • Sponsors Tocagen
  • Most Recent Events

    • 16 May 2018 Status changed from active, no longer recruiting to completed.
    • 07 Feb 2018 According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Feb 2016)
    • 23 Feb 2017 According to a Tocagen media release, the U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of patients with recurrent high grade glioma (HGG). Data from this study supported the application.
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