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A PHASE IA/IB, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETIC, AND EFFICACY STUDY OF TAS4464 IN PATIENTS WITH ADVANCED MALIGNANCIES

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Trial Profile

A PHASE IA/IB, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETIC, AND EFFICACY STUDY OF TAS4464 IN PATIENTS WITH ADVANCED MALIGNANCIES

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs TAS 4464 (Primary)
  • Indications Pancreatic cancer; Rectal cancer; Soft tissue sarcoma; Solid tumours; Uterine cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Taiho Pharmaceutical

    • Most Recent Events

    • 09 Feb 2021 Protocol was amended based on liver function test data during the TAS4464 weekly dose regimen in order to diminish effect of TAS4464 on liver function; additional discontinuation criteria for patient enrollment were added and a 14-day lead-in period was newly added to the schedule at all dose levels.
    • 09 Feb 2021 Results published in the Investigational New Drugs
    • 31 Jan 2020 Status changed from recruiting to completed.

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