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A Phase I dose-escalation trial of SI-053

Trial Profile

A Phase I dose-escalation trial of SI-053

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2018

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At a glance

  • Drugs Temozolomide (Primary)
  • Indications Glioblastoma
  • Focus Adverse reactions
  • Most Recent Events

    • 06 Nov 2018 According to A Double Bond Pharmaceutical media release, the company has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The assistance will be given during a pre-submission meeting, where the company is able to get advice on the protocol for the Phase I study before the clinical application is submitted and is expected to be completed in March 2019
    • 10 May 2018 New trial record
    • 04 May 2018 According to A Double Bond Pharmaceutical media release, the data generated using this trial model will be submitted to regulatory authorities, as part of a Phase I clinical trial application for SI-053 in European Union.
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