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A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-[131I]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1Study

Trial Profile

A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-[131I]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1Study

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Nov 2018

At a glance

  • Drugs ACD 101 (Primary)
  • Indications Glioblastoma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms IPAX-1
  • Most Recent Events

    • 18 Oct 2018 Status changed from planning to recruiting, according to a Telix Pharmaceuticals media release.
    • 18 Oct 2018 According to a Telix Pharmaceuticals media release, the Company has received European Competent Authority (CA) approval to commence a clinical trial of TLX101 for the treatment of recurrent glioblastoma. The first authority to approve the trial is the Austrian Bundesamt fur Sicherheit im Gesundheitswesen (BASG), the Austrian Federal Office for Safety in Health Care. Clinical sites in other European countries and Australia will follow, subject to relevant ethics and regulatory approvals.
    • 15 Sep 2018 New trial record
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