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Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas

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Trial Profile

Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 17 Jul 2023

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At a glance

  • Drugs NUV-422 (Primary)
  • Indications Advanced breast cancer; Brain metastases; Glioblastoma; Glioma; Male breast cancer; Prostate cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Nuvation Bio

    • Most Recent Events

    • 01 Aug 2022 According to a Nuvation Bio media release, company discontinued clinical development of NUV-422.The decision is the result of an internal risk-benefit analysis factoring in feedback received from the U.S. Food and Drug Administration (FDA) in a partial clinical hold letter for the for NUV-422-02 and clinical hold letters for NUV-422-03 and NUV-422-04 studies.
    • 01 Aug 2022 Status changed from active, no longer recruiting to discontinued, according to a Nuvation Bio media release.
    • 29 Jun 2022 Status changed from suspended to active, no longer recruiting.

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